https://CAREERS.PLANET-PHARMA.COM/ en-us Target PR Range: 52-62/hr
*Depending on experience

The Quantitative, Translational ADME Sciences (QTAS) department is seeking a highly motivated scientist to join the Biologics bioanalysis, characterization, and proteomics group. The main function of this position is to develop and implement LC/MS (liquid chromatography/mass spectrometry)-based bioanalysis and in vitro characterization assays for novel biologics entities. The successful candidate will be experienced in the development, optimization and implementation of novel and routine LC/MS-based bioanalytical methods to support in vivo PK, TK, and PK/PD studies as well as in vitro stability characterization of therapeutic proteins, peptides, ionizable lipids and oligonucleotides. The candidate will be responsible for sample preparation, method development, bioanalytical assay operations, data analysis, report generation, and data presentation.

Key tasks and responsibilities:
• Operate and maintain LC/MS instruments to generate high-quality experimental data.
• Perform affinity purification of therapeutic proteins (including but not limited to monoclonal and bispecific antibodies, antibody drug conjugates, antibody-siRNA conjugates, and fusion proteins) from biological matrices.
• Extraction of lipids from biological matrices.
• Analyze data and maintain detailed, accurate and comprehensive study documentation in electronic laboratory notebooks.
• Facilitate assay optimization and implementation to ensure laboratory capacity and data quality.
• Communicate data interpretation internally and externally.

Qualifications:
Degree in chemistry, biochemistry, pharmacology or other related fields. BS with 5+ years or MS with 2+ years or Ph.D 1+ years in a pharmaceutical industry setting with a focus on mass spectrometry.

• Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as a team player and individual contributor.
• Prior industry experience in drug discovery/development is preferred. In-depth understanding of PK, TK and PK/PD studies and corresponding bioanalytical assays as well as in vitro characterization assays is highly desired.
• Hands-on experience with QQQ (SCIEX), qTOF (Agilent, Bruker, SCIEX) and/or Orbitrap (Thermo) mass spectrometers is highly desired.
• Hands-on experience with automated liquid handling systems is highly desired.
• Hands-on experience with oligonucleotide analysis is highly desired.
]]> Sat, 14 Mar 2026 00:00:00 EDT 1
JOB DESCRIPTION

The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of the company's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands-on experience working with biologics including but not limited to proteins, peptides, protein-conjugates, enzymes, biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.

RESPONSIBILITIES

Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences

Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC-MS (high-res) experience is also desirable.

Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).

Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).

Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.

Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.

Other duties as assigned.

Skills

Required Skills:

Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein-conjugates is required.

Experience with biochemical characterization methods is required:

SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)

Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)

cIEF (Maurice) experience is highly desirable

LC-MS (Orbitrap/QToF/QQQ) method development experience also desirable

Technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications, and method transfers.

Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.

Demonstrates attention-to-detail and “right-the-first time’ approach

Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.

Ability to influence others effectively and develop collaborative relationships with partner teams.

Familiar with use of statistical software, electronic document management, and laboratory information management.

Ability to effectively analyze complex problems and present results effectively within and beyond the department

Ability to flexibly adapt to changing business needs and meet timelines.

Strong organizational skills with the ability to effectively multi-task and prioritize.

Desired Skills:

Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.

Knowledge of biopharmaceutical process development is a plus.

Experience with automation is a plus.

Experience working in a cross-functional environment.

Good understanding of root cause analysis methodology.

Education

Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.

Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
 ]]> Sat, 14 Mar 2026 00:00:00 EDT 1
TECHNICAL SKILLS
Must Have

• Advanced Excel
• Experience with SAP

Nice To Have

• Access Database Management
• Advanced SQL
• Microsoft Power BI
• Microsoft SQL Query Analyzer
• Tableau

Key Responsibilities:

• Collect, validate, and organize data related to payments and transfers of value to healthcare providers in support of federal Sunshine Act reporting requirements
• Assist in the preparation and submission of accurate and timely Open Payments reports to CMS, ensuring compliance with all applicable regulations and internal policies
• Perform data quality checks to identify discrepancies, missing information, or potential reporting errors in payment and transfer of value records
• Support the reconciliation of financial data across multiple systems including accounts payable, expense management platforms (Concur), and CRM databases
• Maintain detailed documentation of data sources, validation procedures, and reporting methodologies to support audit readiness
• Generate regular reports and dashboards to track reporting metrics, submission deadlines, and compliance status for stakeholders
• Collaborate with cross-functional teams including Legal, Finance, Commercial Operations, and Medical Affairs to gather required data elements
• Respond to data queries from healthcare professionals regarding reported payments and assist with dispute resolution processes
• Monitor regulatory updates and guidance for global transparency reporting requirements from CMS and other jurisdictions as needed
• Maintain organized records and filing systems for all Sunshine Act documentation in accordance with retention policies
• Other duties as needed

 

Education & Experience:

Bachelor’s degree in Data Analytics, Business Administration, Public Health, or related field with 1-2 years of relevant experience
]]> Sat, 14 Mar 2026 00:00:00 EDT 1 We are seeking a highly motivated System Engineer to join our End-to-End Solution Integration Chapter supporting Next-Generation Diagnostic Solutions. In this hands-on role, you will support development, testing, and integration of complex multi-disciplinary systems including instrument and software components.

This role is ideal for a systems-minded engineer with direct industry experience in diagnostics solutions, strong software testing skills, and the ability to influence cross-functional projects without formal people management responsibilities.

Key Responsibilities
Perform hands-on system level integration testing and troubleshooting.
Plan, design and execute verification and validation (V&V) test cases to ensure comprehensive coverage of requirements.
Analyze test results for accuracy, validity, and relevance to user needs.
Support post-launch troubleshooting and field investigations through failure mode and root cause analyses.
Work with cross-functional project teams on key topics such as requirements management, defect management, system integration, etc.
Contribute to system documentation, including requirements, specifications, integration plans, and verification results.
Identify and lead opportunities for workflow simplification, automation, and continuous improvement.

Qualifications
We are hiring a System Engineer with majors in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science. The final compensation will be determined by the candidate's experience and qualifications.

Minimum Bachelors degree with 3+ years of relevant industry experience.
Strong instrument and software troubleshooting skills with the ability to work independently.
Experience in Software testing automation is a plus
Scripting/programming experience (Python, or equivalent)
Excellent written and verbal communication skills to influence cross-functional stakeholders.

Who You Are
You are a fast learner who thrives at the interface of biology, technology, and data. You want to translate complex scientific workflows into reliable, scalable system solutions. You are collaborative, curious, and driven to make an impact across diverse disciplines, and are comfortable operating as an individual contributor with broad cross-functional influence.

Pay ranges between 55-61/hr based on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1

Primary responsibility is to execute routine Microbiology/Environmental monitoring, Raw Materials testing of bulk drug substance and drug product in a multi-product facility.

Executes Raw Material sampling, Microbiological compendial testing and sampling of clean rooms (as applicable).

Proficiency in 1-3 analytical methodologies.

Performs technical and quality review of data.

Responsible for routine lab maintenance work and quality and compliance activities.

Performs duties under supervision and according to standard operating and QC procedures.

Ensures that all data is organized and archived per appropriate workflows and SOPs.

Works with GMP and non-GMP databases to ensure all samples are received, logged, stored, distributed and tracked within defined timelines.

Interacts with Sample Management, QC laboratories and Raw Materials groups to prioritize samples, cross checks SOPs and protocols to ensure all samples have been received and distributed, troubleshoots discrepancies, and relays information back to line management to ensure all samples are tested per appropriate testing schedule.

Coordinates shipment of samples to contract labs and other testing site.

Maintain sampling and testing paper records, equipment logs and other controlled documentation.

Ensure accuracy and completeness of sampling and testing in LIMS system and/or test records.

Maintain cleanliness and orderliness of the labs.

Perform QC-related data entry.

Provides assistance to other group members as needed.

Responsible for transferring samples from cleanrooms to the labs.

Familiar with clean room gowning.
Skills:

• 1-3 years of GMP lab and/or clean room experience.
• Gowning and Aseptic techniques.
• Pipetting skills.
• Must be willing to work all shifts including weekend support if needed but primary work hours are during five days a week.

Education:

• Bachelor’s Degree in a Scientific Discipline, preferably in Microbiology

Pay Rate Range: $20-27/hr depending on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1 Will lead the financial planning and analytics for the company and is instrumental in establishing and driving financial processes. A forward thinker that understands the strategic directions of Finance Leadership and anticipate implications/impacts.

RESPONSIBILITIES:
Manage FP&A to lead financial planning and analytics for the company
Key business partner to organization leaders to build financial forecasts communicate key business drivers and insights, variances to plan, opportunities and risks, and recommendations
Work closely with executive leadership to build long range budget plan Assist with the financial modeling for strategic initiatives, collaborations, and/or partnerships
Coordinates with all levels of management and the business to gather, analyze, summarize, and prepare recommendations on business process and policies.
Oversee and contribute to the preparation of periodical reporting packages, including financial and operating reviews, market analysis and benchmarking
Develop analytical tools to inform financial forecasts and measure financial performance
Lead ad hoc projects to identify opportunities and implement solutions for continuous process improvement
Provide ad-hoc analyses to support decision making within the business
Consolidate financial results during Budget, forecast, quarter-and year-end close cycles and facilitate earnings/guidance preparation by collaborating closely with cross-functional teams
Establish strong relationships within the company to deliver actionable results 

Requirements: 
Bachelor's degree in accounting or equivalent
Minimum of 7 years of progressive finance, accounting, and/or financial planning and analysis experience
Experience in early-stage life science companies
Data driven with strong analytical and critical thinking skill
Ability to manage highly confidential material in an appropriate manner
Excellent verbal and written communication skills, with ability to articulate financial results
Self-directed and able to work well and communicate effectively in a team environment. Hands on and able to work with minimal supervision. Ability to balance multiple deadlines and deliverables.
Exceptional interpersonal soft skills and ability to establish strong rapport and partnerships at all levels of the organization
Experienced user with knowledge of ERP, BI and automated planning systems
Proficiency in Microsoft Project
Previous experience developing financial operating policies and procedures Advanced level of proficiency with Excel, with strong financial modeling skills ]]> Fri, 13 Mar 2026 00:00:00 EDT 0
Job Description

We have a bold Pharma Vision to achieve 3-5 times more patient benefit at 50% less cost to society. With this vision top of mind, Pharma Product Development (PD) Global -inventing how we organize ourselves and work. We seek to create new ways of working, always with the patient at the center of everything we do. Our shared purpose is to innovate clinical trial delivery to transform our patient, caregiver, and site experience to bring better trials to more patients.

We want you to join our mission and be part of our passionate, collaborative, Global Clinical Operations community! We act as one mutually accountable community focused on work that will have the highest impact on our core mission of helping patients across the industrys most robust Development Portfolio. We recognize the individuality and diversity of everyone, the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional job titles and job descriptions. We believe in reducing hierarchy and silos to enable teams closest to the work to deliver impact for patients. We empower and enable people to deliver on outcomes-based work where there is the most business critical and priority impact in moving towards our Pharma Vision.

If this culture and way of working resonates with you, we want you to be a part of our team!

As a Clinical Operations Lead in a cross-functional, matrixed organization, you will be empowered to work with people across PDG and beyond to enable all teams to perform at their best, foster a growth mindset to optimize potential and talent, and flow to high impact work to advance our medicines for patients. You may have the opportunity to work as needed across one or more areas of PDG including: study management, patient/disease areas, biomarker operations, quality management, systems and process development, learning, insights and analytics, as well as strategic focus areas, such as innovation & creativity, investigator centricity & partnering, patient & caregiver benefit, inclusive research, diversity & inclusion, and other areas.

As a Clinical Operations Lead, your responsibilities will include as directed:

* Clinical operations - contribute in operational activities that enable trial execution and delivery of the PD portfolio of clinical studies and programs across Disease Areas by providing operational and/or strategic input to the teams.
* Local and global initiatives
* Other responsibilities according to business needs and priorities
* Promote and support quality and compliance by being accountable for gcp/gvp compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.

You exemplify the following:

* At least 2 to 5 years of relevant experience
* Knowledge of Drug Development and Clinical Operations or related areas
* Ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
* Thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
* Apply organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operations' programs, studies, and/or enabling projects.
* An effective communicator that shares information transparently and strategically; comfortable working out loud and is an active listener.
* Building subject matter expertise on specific clinical operations activities through supporting the execution of clinical trials and/or enabling projects across geographies Collaborating across PDG and other functions to develop and implement best practices across clinical operations and delivery of the portfolio.
* Ability to serve as a resource for colleagues; can work across moderate sized projects with manageable risks and resource requirements.
* Works in rapid cycles (real-time optimization) to prioritize (i.e., determine what work is essential or proposed to stop in order to create the capacity to focus on what matters) and ensure alignments of priorities to the mid- and long-term outcomes.
* Fast adoption, foster changes and being change agents for investigators/patients to adopt new digital technologies in conducting clinical studies.
* Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives. Independently and with some guidance develops plans to support the execution of clinical trials and/or enabling projects.
* Work closely with Investigator and clinical site staff with a continuous focus on partnership and aiming to position us as a preferred partner.






Pay Rate Range: $60-78/hr depending on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1
Job Description:
We are seeking an experienced Accounts Payable Leader to provide interim leadership and operational support for the AP function during a critical period. This role will focus on ensuring payment continuity, stabilizing processes and reducing reliance on manual workarounds.

The ideal candidate has 7-10+ years of hands-on AP leadership experience who can step in quickly, assess issues, drive execution, and partner effectively with Finance, Treasury, IT, and external vendors.

Key Responsibilities
• Lead day to day Accounts Payable operations, ensuring timely and accurate processing of invoices and payments
• Partner closely with IT and Finance teams to address system related issues, ensure production stability, and drive remediation efforts
• Lead and provide clear direction to a developing Accounts Payable team, driving timely execution, rapid issue resolution, and strict adherence to priorities in a high urgency environment
• Proactively address urgent payment issues, escalations, and exceptions to ensure business continuity
• Stabilize AP processes and reduce dependency on manual or workaround solutions
• Ensure compliance with internal controls, SOX requirements, and company policies
• Communicate clearly and effectively with stakeholders, including Finance leadership and business partners, on status, risks, and dependencies
• Document processes and support knowledge transfer as required]]> Fri, 13 Mar 2026 00:00:00 EDT 1
The Opportunity:

• Proactively manage and maintain business partners complex calendars and meetings
• Coordinate and manage complex travel needs and logistics
• Plan large mid-level, internal meetings (e.g. department meeting, large team/committee)
• Possess advanced knowledge of Genentech IT systems (ex: cSuite, virtual collaboration tools, etc.)
• Manage relationships with internal and external stakeholders, often with a high level of confidentiality required
• Create contracts/purchase orders, and process payment and expense reports.
• Help coordinate candidate/interview process
• Manage and plan team building events & workshops ( depending on role and level)
• Independently lead the planning & execution of complex team offsites (involving multiple locations, days, activities, and/or travel needs)
• Draft email communications on behalf of manager, team, department, leader, etc
• Manage departmental gSites, Slack, websites, newsletters, etc. (collect content, distribute information, oversee maintenance)
• Project Management support: Quality Compliance & Clinical Capabilities (QC3) projects & initiatives
• Additional responsibilities assigned (based on business need)

Who You Are:

• Ability to multitask, prioritize and execute tasks independently. May assist in the coordination of work flow among team members
• Collaborative, initiates and facilitates team development, ensures all relevant or useful information within the team is shared, works with different functions to achieve the best overall outcome
• Ability to handle and exercise judgment and discretion concerning sensitive, confidential and proprietary information
• Demonstrates accuracy and attention to detail of own and other's work, communicates and ensures standards for accuracy and detail within the team
• Based on breadth of experience, skill and strategic context, makes decisions independently and with minimal need of external input/validation
• Experience working with senior leaders/management
• In depth knowledge of Microsoft Office (Power Point, Excel and Word), cSuite Tools (including gMail, gCal, gSheets, gSlides, Trello, Jamboard, gMeet, ZOOM) and able to provide instruction or training to others as needed
• An average of 5-7 years related administrative, operations or project management experience (experience gained in pharmaceutical / biotechnology industry is preferred.)
• BS/BA degree or equivalent industry experience

Pay Rate Range: $25-32/hr depending on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1 SUMMARY/JOB PURPOSE:

This company is seeking a Sourcing Contract Manager to join the Pharmaceutical Operations and Supply Chain (PSC) Contracts team, reporting to the lead for Contracts & Budgets & Outsourcing.  You will be responsible for supporting the team in contract management activities such as administering, writing and execution of the contracts related to PSC team. Where required, this role will be required to support and assist in escalations and resolution of payments that have been committed to a supplier. You will support and collaborate with various internal and external business teams to address contracts and financial requests.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

• Write/draft Statement of Works (SoWs) and Change Orders (COs) associated with low-risk contracts leveraging the Agiloft Legal Contract Lifecycle Management (CLM) system.
• Advise and troubleshoot on existing agreements under the guidance of the assigned team member.
• Attend cross functional internal and external supplier meetings to ensure supplier contract terms and conditions are adequately addressed and contracts executed in a timely manner.
• Responsible for the routing, tracking and facilitating the timely progress of contracts from point of submission into PSC through to execution.
• Responsible for the creation of purchase requisitions to enable the PSC business to commence work with the scope of the executed contract.
• Where required assist and support continuous improvement activities to improve the team’s ability to deliver value to the business.
• Facilitate and support budget forecasting and accrual activities where required.
• Provide support during any financial audits at month or quarterly close, as needed.
• As applicable per designated PSC business, maintain GxP and financial audit inspection readiness.

 

SUPERVISORY RESPONSIBILITIES:

None

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and 3 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

 

Experience/The ideal for Successful Entry into the Job:

• The ideal candidate must have 1-2 years of direct working experiences in the life-sciences industries emphasis on contract drafting and sourcing negotiations with preferably outsource services such as contract manufacturers (CMOs), and/or clinical research testing laboratories.
• Collaboration with multi-functional teams.
• Working knowledge of clinical and commercial supply chain contract terms and conditions.
• Experience in negotiating and drafting complex contract manufacturing, biologics and clinical and commercial supply chain related agreements.
• Experience in SAP, Ariba, Tableau and management of both clinical and commercial supply chain, required.
• Experience in Contract Life Management (preferred Agiloft) system.

 

Knowledge/Skills:

• Some understanding of the contract management process, including tracking, negotiation, approval and signature processes.
• Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred.

• Ability to work effectively across a variety of functional groups such as Commercial, Research and Development, Chemistry Manufacturing Controls (CMC), Clinical Studies and Finance,) and all levels of management.

• Ability to work with vendors and effectively negotiated commercial terms.
• Flexible and willing to learn new procedures and skill sets.
• Must be detail oriented and have strong organizational skills.
• Ability to handle multiple tasks simultaneously.
• Ability to prioritize; must be responsible and conscientious.
• Ability to work under pressure to meet specific deadlines.
• Dedication to quality and reliability in all work tasks.
• Excellent verbal and written communications skills.
• Must embrace the company core values: Be Exceptional, Excel for Patients, and Exceed Together.

]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Interested in candidates that have a good balance of analyst and technical skills on the ServiceNow platform. The other key attribute is strong communication skills, so they will be able to lead effective conversations regarding business requirements and platform capabilities.

Job Title: ServiceNow Technical Analyst

Position Overview:
We are seeking a skilled ServiceNow Technical Analyst to join our team on a contract basis, supporting Lauren Kennedy in strategic platform initiatives. The ideal candidate will possess deep expertise in ServiceNow and demonstrate strong business analysis capabilities, including the ability to engage with cross-functional teams, gather and document business requirements, and translate them into actionable technical solutions.

Key Responsibilities:
Collaborate with business stakeholders to understand and document functional requirements.
Analyze and translate business needs into ServiceNow workflows, configurations, and enhancements.
Support the design and implementation of ServiceNow modules including ITSM, ITOM, and business service requests.
Create and maintain documentation including process flows, user stories, and technical specifications.
Assist in testing, validation, and deployment of ServiceNow solutions.
Provide ongoing support and troubleshooting for ServiceNow-related issues.
Work closely with the ServiceNow platform team and other IT teams to align technical solutions with business goals.

Required Qualifications:
At least 5 years of experience as a ServiceNow Technical Analyst or Administrator.
Strong technical and functional ServiceNow skills
Strong understanding of ServiceNow architecture, modules, and capabilities.
Experience gathering and documenting business requirements and translating them into technical specifications.
Excellent communication and stakeholder engagement skills.
Ability to work independently and manage multiple priorities in a fast-paced environment.

Preferred Qualifications:
ServiceNow certifications (e.g., CSA, CIS-ITSM).
Experience in enterprise environments or strategic platform initiatives.
Familiarity with Agile methodologies and tools.]]> Thu, 12 Mar 2026 00:00:00 EDT 1 The Analytical Operations (AO) department is seeking an enthusiastic and motivated Research Associate to be part of our analytical testing team. This role utilizes analytical tools to characterize the physical and chemical properties of biopharmaceutical products. This work is essential for supporting both process development and validation, and for determining product quality, purity, and stability.

About Analytical Operations (AO)
Analytical Operations (AO) is a non-GMP department within the PTDA Analytical Development Quality Control organization, dedicated to advancing the company's R&D pipeline. The department is focused on providing technical expertise and analytical support for early-stage research, development, and process validation for departments across the South San Francisco campus as well as other internal sites. This support is delivered through high-throughput testing, automation, effective data management, and robust business processes, all of which facilitate timely and scientifically informed decisions.

Key Responsibilities

• Conduct routine and non-routine analytical testing using a variety of physiochemical techniques (U/HPLC, icIEF, CE-SDS, and LC-MS), according to established protocols.
• Maintain accurate, detailed documentation of assays and data results in an Electronic Laboratory Notebook (ELN), strictly adhering to ALCOA+ principles.
• Perform essential lab support tasks, including stocking consumables, checking for expired reagents and hazardous waste, and de-icing freezers.
• Comply with laboratory best practices, safety guidelines, and internal and regulatory standards.

Job Requirements

• Bachelors degree with a minimum of 3 years of relevant experience, or a Masters degree with laboratory experience in Chemistry, Biochemistry, or a related scientific field. Experience in the biotech or pharmaceutical industry is preferred.
• Must be highly organized, detail-oriented, and self-motivated, with a proven ability to successfully manage multiple tasks, both independently and collaboratively as part of a team
• Hands-on experience with HPLC/UPLC, CE, or LC-MS is required.
• Strong written and verbal communication skills are a must, with the ability to present technical work clearly.
• Knowledge of GMP compliance, experience with ELN, and intermediate proficiency in Microsoft Excel is highly desirable.
• Ability to lift 20 lbs. for laboratory-related tasks.

Pay Rate Range: $20-26/hr depending on experience ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 JOB SUMMARY:
We are seeking a Compliance Specialist to contribute to our growing Analytical Development team. The Compliance Specialist will participate in all aspects of compliance and development management in Analytical Development, working closely with cross-functional teams to onboard instruments/equipment, performing data/document/record review, and authoring various compliance documents.
This position may also require hands-on laboratory experience from time-to-time working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for company projects.
This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support and compliance management.

Job Responsibilities:

• Work closely with the CMC team to manage and coordinate analytical activities
• Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Assist in authoring and reviewing various regulatory submission and interaction documents
• Assist in the developing, authoring, and/or reviewing standard operating procedures
• Manage reference materials and reference standards inventory and (re)qualification testing
• Manage vendor maintenance and calibration for AD-owned equipment, instruments, and systems
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Skills:    

• Experience in drafting protocols, methods, reports, and/or procedures.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools preferred.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.

Preferred Qualifications:

• Demonstrated experience in managing outsourced analytical activities
• Demonstrated experience in QC data review of release and stability data packages
• Experience in Liquid Chromatography and/or Immunoassays is highly desired.

Education:    

• Bachelor’s degree in biological sciences or related field with 4+ years of progressive experience in the biotechnology or pharmaceutical industry.
• 3+ years of experience in a regulated/GMP environment.
• 2+ years of experience in a quality function (QC or QA organization)

Pay Rate Range: $45-55/hr depending on experience ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Description 
The Senior Manager/ Associate Director, Engagement Platforms and Reporting will support roadmap, implementation and maintenance of technology platforms and measurement reporting for Medical Engagement activities across Global Medical Affairs (GMAF). He/she will support functional Medical Engagement Leads with platform implementation and ongoing maintenance with emphasis on field medical related-systems. Additionally, he/she will implement key measurement framework and reports across breadth of external engagements including field medical, congresses, society engagements, medical education, and other activities.

This role will sit within the Medical Engagement (ME) group as part of the larger Medical Excellence Team within GMAF. He/she will support the various Leads across Medical Engagements, partner closely with our commercial teams, Information Technology, and partner with GMAF colleagues, specifically from strategic markets, to maximize end user implementation. This role will maintain a focus on key strategic markets and assets / indications in line with company priorities.
 
Key areas of responsibility:

• Oversee the development, implementation, evaluation and maintenance of key platforms, systems, technology and associated trainings to support GMAF Medical Engagement
• Develop engagement measurement framework on key activities to enhance impact of medical affairs
• Lead reporting for GMAF with prioritization against GMAF needs and strategic capabilities
• Support GMAF roadmap execution through respective digital activities
• Manage vendor relationships and collaboration for project execution
• Ensure effective data capture across medical activities to quantify KPIs, metrics and overall impact
• Liaise with key stakeholders across medical affairs to ensure technology is enhancing user workflow and evolving ways of working
• Key point of contact with enterprise stakeholders including commercial digital, information technology, etc. to ensure alignment with enterprise level projects
• Manage project logistics including overall phasing, budget and resourcing throughout lifecycle
• Serve as single point of contact for digital platform, systems and technology needs
•  

 
Additional responsibilities may include:

• Working cross-functionally and collaboratively to communicate the ME priorities and roadmap internally; ensure alignment, coordination, and resourcing to execute the strategic plans with leadership and matrix teams appropriately
• Collaboration with the Medical teams and additional cross-functional internal stakeholders to create and initiate innovative strategies, programs, and tactics in alignment with the company's business objectives and specific therapeutic area strategic imperatives
• Develop partnership with internal and external stakeholders
• Collaborate cross-functionally across GMAF organization, regions/ countries, and enterprise partners

Qualifications (from An Accredited College Or University)

• 4+ years experience in a pharma / biotech preferred,
  • Key consulting or technology experience may be considered

• Experience in key Pharma / Biotech technology systems such as Veeva suite, Salesforce suite, etc. preferred
• Experience in measurement / reporting of medical affairs activities preferred
• Experience in project development and execution with IT, legal, compliance

• Demonstrated expertise in working successfully with cross-functional teams to achieve results preferred
• Scientific training (PharmD, PhD, or MD) optional

]]> Thu, 12 Mar 2026 00:00:00 EDT 1
AP Email Inbox
•       Wholly owns AP inbox and reviews each email thoroughly
•       Respond to all general inquiries and only delegate emails to the respective analyst if:
•       The email is a response in a thread between the sender and analyst
•       The email is a complex inquiry that requires a higher-level response

Mitigate Escalations
•       Review each email and alert the appropriate team member should it appear that it's moving in the direction of escalation. If something is clearly escalating, alert Sr. Manager for visibility.
•       If an email is unable to be answered in a timely fashion, an acknowledgement will be provided to the sender to assure them that their email is being addressed, but there may be a delay due to (insert brief description of reason).

Physical Mail
•       Scan invoices to processing team
•       Review statements to determine whether necessary to distribute to respective analyst or not
•       Reach out to suppliers sending physical mail and request that invoices/statements solely be emailed to AP to reduce duplicate efforts and waste consumption

A/P Floater
•       Backup to analysts when they are out of the office.

Financial Disclosures & Escheats Audits
•       Support per Regulatory team requests; review findings with Sr. AP Manager upon completion
•       Escheats audit fulfillment; align with tax team if/when request is received

Invoice Entries
•       Refunds, credit/debit notes, disbursement requests, tax payments, etc. as instructed by AP Sr. Associate

 ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Pay 38-42/hr depending on experience

Duties
• End-to-end contract management, including receiving and submitting, monitoring and tracking a large volume of contracts from draft through final signatures
• Monitoring and tracking a large volume of requisition requests from submission to financial approval and PO creation
• Creating and submitting contract and financial requisition requests using SAP/Ariba (contracting & procurement platform) and Coupa/Spend Source (spend management tool)
• Researching vendors in systems to determine if vendors are active, prior to contracting new relationships; handle new supplier submissions or updating existing suppliers as necessary
• Drafting and routing multiple contract types for review/negotiation: Non-Disclosure Agreements, Scopes of Work, and Change Orders
• Acting as a liaison between the company, internal business partners, and outside vendors to facilitate contract execution
• Building and maintaining relationships with internal business partners
• Engaging with other functional areas within the company to assess and respond to contracting and requisition needs, obligations, and revisions
• Monitoring and coordinating complex workflows between the business, Procurement, Finance and Legal Departments to ensure tasks move forward in a timely manner

Skills
• Prior experience in contract management required
• Strong acumen for SAP/Ariba and Coupa/Spend Source platforms
• Comfortability with ambiguity and navigating complex processes and systems
• Ability to work autonomously and proactively, capable of troubleshooting and figuring things out
• Detail-oriented: strong proofreading and editing skills
• Strong computer skills in database management and document preparation (Word, PowerPoint, Excel)
• Ability to manage heavy workload and aggressive timelines in a timely manner, prioritize, and work under pressure
• Strong written and verbal communication skills
• Customer service oriented: must be able to communicate effectively with internal business partners as well as external vendors/suppliers
Preferred:
• Experience in contracts administration or other relevant experience is strongly preferred.
• Experience at a large law firm or within an in-house legal department of a public company a plus.
• Experience within biotech/pharma/medical device industry or other contract-intensive fields a plus.
• Familiarity with SpringCM is a plus.
• Science background is a plus

Education
• Prior experience]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Position Summary

The Sr. Clinical Research Associate (CRA) will manage clinical aspects of a larger-sized clinical study or, with supervision, assume some management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.
 

• Local candidates, who can work in the SSF HQ office 2-3 days per week

Essential Duties And Responsibilities
 

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.
• Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
• Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
• Helps to oversee aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
• Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
• Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level.
• May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
• Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables.
• Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows.
• Participates in the development, distribution, review, and tracking of essential trial documents.
• Strives to ensure timelines and deliverables are met within budget.
• Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes.
• Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution.
• Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.
• Liaises internally to forecast and monitor overall drug supply throughout the trial.
• Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality.
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits.
• Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done.
   

TRAVEL

Up to 30%

Requirements

Education
 

• Bachelor’s degree in a relevant scientific discipline
• Minimum 3-4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting.
   

Experience
 

• Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus.
• A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
• Self-motivated and able to motivate others.
• Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
• Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.
• Proficiency in Microsoft suite or products such as Word, Excel etc.

]]> Thu, 12 Mar 2026 00:00:00 EDT 0 Position Summary: Sr CTA

The Senior Clinical Trial Associate (Sr CTA) acts as a central contact for the designated clinical study team and in this key support role supports the team in the planning, implementation, and completion of clinical studies both outsourced or in-house, through interaction with investigative sites, vendors, and team members. The CTA, under the direction and guidance of team members will work independently but knows when to involve and or collaborate with other functional members in the execution of role & responsibilities.

 

Job Responsibilities:

• Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
• Sets-up and maintains/ closes out the Trial Master File (TMF/eTMF), perform QC as assigned and resolves discrepancies.
• Maintain and update study metrics as necessary, including, but not limited to: Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, etc.
• Facilitate with the preparation of agendas and takes comprehensive minutes for internal and external meetings.
• Accountable for study level tracking as assigned, e.g. monitor visit tracking, sample tracking, study related supplies etc.
• Assists in preparing materials for investigator meetings, monitor workshops, and study manual.
• Communicates and coordinates with team members to ensure accurate and comprehensive completion of documents by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines.
• Interfaces with other cross functional groups to coordinate relevant and timely exchange of information / materials as assigned.
• Assist with data reconciliation, as required.
• Participate in the review of clinical data in the clinical database, data listings, and reports, as assigned.
• Update and maintain public clinical trial listings/postings (e.g., www.clinicaltrials.gov, EUDract registry, etc.).
• Assist with clinical trial insurance policies (includes obtaining and reviewing policies for new studies, tracking and renewing expiring insurance certificates, etc.).
• Prioritizes and plans work activities; Uses time efficiently to meet deadlines.
• May be assigned additional responsibilities based on study needs.

 

Qualifications:

Education

• Bachelor’s degree in a relevant scientific discipline

Experience

• 2+ years with biotechnology/pharmaceutical/clinical trial management experience. Global experience a plus.
• Familiarity with document filing/management in an eTMF environment Excellent communication and interpersonal skills
• Effective organizational skills and a high regard for attention to detail
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Proficiency in Microsoft suite of products such as Word, Excel etc.

Travel Required: Up to 20%
]]> Wed, 11 Mar 2026 00:00:00 EDT 0
Essential Duties and Job Functions:
• Support the lead training manager by managing assigned components of training initiatives (i.e. planning, execution and follow up) to ensure timelines, quality and objectives are met.
• Lead and collaborate on the development and implementation of knowledge/skill-based training focused on ensuring success through therapeutic disease state and product knowledge for commercial field sales
• Develops and executes training with a specific focus on our new hire program Accelerate as well as account management skills, product knowledge, new promotional campaigns, product launches, communication skills, selling skills, phased trainings, sales meeting training workshops, ongoing learning sustainment programs & other as needed field sales.
• Collaborates with and supports relevant internal departments, including Marketing, Commercial (Field Sales, National Accounts, Regional Trainers), Commercial Operations, Global L&D, Medical Information, Legal, Business Conduct and Regulatory to develop appropriate training.
• Collaborates with internal customers including Compliance/Legal, Marketing and Medical Information to ensure training materials and workshops are current, effective and compliant with regulatory guidelines.
• Partners with external vendors to design curricula or programs and planning of instructional methods and materials using adult learning principles.
• Effectively prepares for instruction by conducting needs assessments, identifying targeted participant characteristics, and soliciting cross-functional feedback before finalizing design and strategy.
• Offers solutions for bridging gaps between current organizational capabilities and needs.
• Helps ensure readiness of the organization for training deployment including identifying key stakeholders and determining their needs in advance, in order to deliver high quality and effective programming.
• Analyzes the characteristics of existing technologies and their use in instructional design.
• Partners with subject matter experts and key stakeholders to identify training needs, improve training solutions and lead change initiative implementation.
• Monitors and maintains alignment with Commercial groups strategic training plan while balancing short-term and long-term business goals.
• Manages budget aligned with both the development of training resources and / or POA / Sales Meetings

Knowledge, Experience and Skills:
• Proficiency in Microsoft Office applications including Word, Teams and PowerPoint, particularly as used in the development of instructional content.
• Highly self-motivated and self-managed; ability to work independently and as part of a team with minimal coaching or supervision.
• Ability to organize and work under strict time and production deadlines, while producing quality deliverables.
• Good organization skills, time management, and the ability to juggle multiple tasks are all prerequisites of an effective project manager.
• Excellent facilitation and communication skills.
• Demonstrated ability to simultaneously handle a large and diverse number of technical tasks and issues with tact, cooperation and persistence.
• Demonstrated ability to build consensus and gain alignment with key stakeholders
• Demonstrated ability to lead without authority
• Strong organizational and problem-solving skills.
• Comfortable working with people at all levels of the organization globally as well as with suppliers, vendors and customers.
• Ability to effectively communicate in visual, oral and written presentation forms.
• Ability to effectively manage a project from its initiation to delivery, either as live training or as a virtual deliverable.
• Ability to effectively manage multiple vendors from selection to final deliverable
• Must have the ability to focus on performance by establishing clear objectives for the training.
• Strong interpersonal communication, facilitation, problem solving, decision making and analytical skills.

Minimum Experience:
• High School Degree and Twelve Year's Experience
OR
• Associates Degree and Ten Years Experience
OR
• Bachelor's Degree and Eight Years Experience
OR
• Masters' Degree and Six Years Experience
OR
• Ph.D.

Preferred Experience:
• MS degree plus 6 years in related field is desirable
• 5+ years of commercial pharmaceutical/biotech experience
• 3 years of successful Field Sales experience
• 1 year Prior commercial training experience
• Experience in HIV is preferred, launch experience preferred
• Sales, marketing, or training experience in a competitive biotech/pharma marketplace

Pay ranges between 70-73/hr ]]> Wed, 11 Mar 2026 00:00:00 EDT 1
Introduction:
The Senior Administrative Assistant position within the Pharmacovigilance team is integral to the effective operation of Global Patient Safety (GPS). Serving as a primary support to the Head of Global Pharmacovigilance and the wider GPS team, this role requires a blend of advanced administrative capabilities, collaborative skills, project coordination, and strong organizational acumen. The following overview details key responsibilities, expectations, and the professional competencies required for success in this important capacity.

Position Structure and Reporting
This position directly supports the Head of Global Pharmacovigilance, who provides strategic and operational leadership for GPS. The Senior Administrative Assistant is positioned at the core of departmental activities, requiring sound judgement, discretion, and the ability to effectively engage with stakeholders across departments. As a central point of contact, the assistant facilitates communication and supports a wide range of operational and project-based needs.
Primary Responsibilities

The Senior Administrative Assistant’s core duties include:
• Meeting Coordination: Proactively schedule and organize meetings and conference calls, ensuring availability of all participants, reserving meeting spaces, arranging technical setup, coordinating catering, preparing materials, and recording minutes as needed. The assistant must anticipate and resolve scheduling conflicts to ensure meetings are productive and well-attended.
• Offsite Event Management: Oversee logistics for offsite meetings, including hotel and restaurant bookings, catering arrangements, and planning team-building activities. This responsibility involves thorough research, negotiation, and organizational skill to deliver seamless events in line with departmental objectives.
• Travel Coordination: Arrange all business travel in accordance with company policy, managing flight, accommodation, and transportation bookings while adhering to budgetary and compliance requirements and considering traveler preferences.
• Expense Management: Prepare and process expense reports accurately and promptly using systems such as Concur, ensuring full documentation and timely reimbursement.
• Office Supply Oversight: Monitor and replenish departmental supplies, ensuring availability of materials necessary for daily operations.
• Technical Liaison: Serve as the point of contact for IT-related issues, facilitating timely resolution and supporting ongoing productivity for GPS team members.
• Meetings Participation: Actively participate in GPS meetings, both on-site and off-site, contributing to effective communication and operational continuity.

Additional Departmental Support
• Calendar Management: Maintain and coordinate calendars for GPS leadership and the broader department, preparing for and supporting team and staff meetings.
• Contract Administration: Submit and track department contract requests within the contract management system, ensuring accurate status monitoring.
• Invoice Tracking: Monitor and reconcile departmental invoices, ensuring financial accuracy and timely payments.
• Project Tracking: Develop and maintain departmental project trackers and spreadsheets, follow up on deliverables, and synthesize information for status reporting.
• Document Management: Organize and maintain departmental files within the document management system, ensuring accessibility and safeguarding institutional knowledge.
• Contact List and Organizational Chart Management: Regularly update departmental contact lists and organizational charts to reflect changes and facilitate efficient communication.

Core Competencies
• Planning and Coordination: Ability to manage multiple tasks and priorities in a fast-paced, deadline-driven environment while maintaining attention to detail.
• Technical Proficiency: Advanced knowledge of Microsoft Office Suite, Concur, SharePoint, and other business tools required for efficient workflow.
• Communication and Interpersonal Skills: Strong written and verbal communication skills to foster professional interactions with internal and external partners.
• Detail Orientation and Responsiveness: Commitment to meeting deadlines and ensuring thorough, accurate, and compliant work products.
• Initiative and Independence: Demonstrated ability to work independently, quickly learn new tasks, and proactively anticipate departmental needs.

Qualifications and Experience
• Minimum 5 years’ administrative experience in the biotechnology or pharmaceutical industries. Experience supporting pharmacovigilance functions is highly desirable.
• Bachelor’s degree highly preferred]]> Wed, 11 Mar 2026 00:00:00 EDT 1 Target PR Range: 31-41/hr
*Depending on experience

SUMMARY/JOB PURPOSE: 

This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs).  This role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting.

This role provides support and oversight of all aspects of drug safety study operational activities from study start up to close out.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Technical duties include but are not limited to:

• Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing.
• MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization.
• Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
• Scheduling submissions of expedited safety reports in ARGUS as needed.
• Training of new safety staff on Argus and case processing.
• Collaborating with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
• Performing Safety Study Lead activities including:
  • Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician.
  • Development of study specific safety management plan from Drug Safety template
  • Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
  • Perform SAE reconciliation, as required by safety management plan.
• Additional duties and responsibilities as required.

 

SUPERVISORY RESPONSIBILITIES:

• None

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 

Education/Experience:

• BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or,
• MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or,
• PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

 

Experience/The Ideal for Successful Entry into Job:

• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.
• Clinical trial and spontaneous adverse event processing experience.

 

Knowledge/Skills:

• Knowledge of biotechnology/pharmaceutical sector.
• Knowledge of regulatory framework governing patient safety.
• Adopts an analytical approach to solve problems relevant to the role.
• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner.
• Works collaboratively with team members.
• Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolution.
• Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members.

 

JOB COMPLEXITY:

• Capable of following predefined procedures for specific tasks.
• Capable of identifying task-related challenges and prioritizing activity accordingly.
• Identifies and escalates issues that may have a broader impact.
• Implements solutions to address any task-related challenges.

*CO/NYC candidates might not be considered
]]> Tue, 10 Mar 2026 00:00:00 EDT 1
Responsible for a variety of activities related to contracts management and compliance for corporate development such as, negotiating, structuring, and/or administrating contractual documents that establish business relationships with vendors, customers and/or partners. Serves as a liaison between groups such as, Corporate Development, Sales, Legal and technical departments regarding contractual information. Analyzes contracts to ensure compliance to company policy, government specifications and other requirements.

Resolves a wide range of issues in imaginative as well as practical ways. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Performs a combination of planning, developing and recommending best methods to achieve contract goals and objectives. Tracks contract performance and compliance. Works to ensure adherence to established contracting policies and procedures. Monitors the progress of contracts and helps to compile reports on contractual performance, financials and compliance. Compiles contractual information for budget and financial information, complex cost reimbursements and billing. Disseminates information to critical personnel with regard to changes and updates relating to contracts. Interfaces with a variety of internal and external customers providing guidance and information on contractual matters to meet requirements for contracts. Maintains contract and customer databases and files. Provides a variety of reports to senior management. Performs other contracts related activities and tasks as assigned.

Requirements:
A minimum of Bachelors degree in Business Administration or related discipline is required. Professional certification or advanced degree is a plus. Equivalent experience may be accepted. A minimum of 4 years of directly related experience is required. Previous experience working in the pharmaceutical, biotechnology or medical device industry is preferred. Previous experience with external relationship management is required. 
 ]]> Tue, 10 Mar 2026 00:00:00 EDT 1 Scientific Researcher
Synthetic Molecule Pharmaceutical Sciences
Position Summary
We are seeking an outstanding Scientific Researcher to support formulation screening efforts within the Synthetic Molecule Pharmaceutical Sciences group. The successful candidate will contribute to the development and optimization of lipid nanoparticles (LNPs) and other parenteral formulations through high-throughput screening strategies and advanced analytical characterization. This role requires hands-on laboratory expertise, strong analytical skills, and the ability to work collaboratively within cross-functional teams to support pharmaceutical formulation development.
Responsibilities

• Design and execute high-throughput formulation screening experiments for lipid nanoparticles (LNPs) and other parenteral drug delivery systems, using both bench instruments and automation tools.
• Physicochemical characterization of LNPs including particle size distribution, encapsulation efficiency, zeta potential, stability testing, etc.
• Solubility and stability screenings, solid state/polymorph characterizations to support formulation research and development.
• Design, plan, and troubleshoot laboratory experiments while maintaining strong attention to data quality and reproducibility.
• Analyze and interpret experimental data, generating clear reports, presentations, and summaries for project teams.
• Document experimental procedures and results in electronic laboratory notebooks (ELN) and internal data management systems.
• Collaborate with analytical scientists, formulation scientists, and cross-functional project teams to support development programs.
• Identify technical challenges and propose potential solutions to improve formulation performance and experimental workflows.
• Maintain compliance with laboratory safety standards, internal quality requirements, and regulatory guidelines.

Required Qualifications

• BS or MS degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
• 1 - 5 years of industrial experience in pharmaceutical formulation research and development.
• Strong theoretical knowledge of pharmaceutics; analytical, physical, and/or organic chemistry.
• Hands-on experience with LNP formulation and analytics, including microfluidics, dialysis and ultrafiltration, particle sizing, encapsulation efficiency analysis.
• Self-motivated with strong problem-solving capabilities to design and execute experiments independently.
• Excellent written and verbal communication skills to work effectively in a collaborative team environment.

Preferred Qualifications

• Hands-on experience with analytical tools including UV/Vis/fluorescence spectroscopy, HPLC-UV/CAD/MS, capillary electrophoresis, or related technologies.
• Experience in analyzing peptides and nucleic acids.
• Experience with lab automation and hands-on experience with robotic liquid and solid handlers.
• Experience performing high-content data analysis, AI/ML, and interpreting complex experimental results.

Key Skills

• Pharmaceutical formulation development
• LNP and parenteral formulations
• High-throughput experimentation
• Analytical chemistry techniques
• Data analysis and interpretation
• Laboratory automation technologies
• Scientific problem solving
• Cross-functional collaboration

Pay Rate Range: $35-47/hr depending on experience ]]> Tue, 10 Mar 2026 00:00:00 EDT 1 Position Summary:  Manager, Clinical Supplies Planning and Logistics

Structure is seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. They will also be involved in typical Clinical Supplies Manager activities including forecasting Investigational Product (IP) supply requirements, inventory management, and managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Will collaborate and interact internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots). This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
ESSENTIAL DUTIES AND RESPONSIBILITIES

• As part of the Clinical Supplies Planning and Logistics team, manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label generation and approval, packaging and labeling operations at clinical supply vendors, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
• Collaborates with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
• Manages the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Provides input to drug kit randomization specifications and reviews master kit lists

Qualifications:
Education

• BA/BS required, scientific discipline preferred. Other BA/BS degree with IRT and clinical supply experience will be considered.

Experience

• Understanding and proven experience in IRT/RTSM in large global blinded studies
• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management using IRT in a small biotech-type of environment.
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies preferred
• Experience in IP logistics in Latin America preferred
• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
• Experience in forecasting, labeling, and distribution in a clinical environment

]]> Mon, 09 Mar 2026 00:00:00 EDT 0 Position Summary: Sr. Clinical Trial Manager (Sr. CTM)

Seeking a highly motivated Sr. Clinical Trial Manager (Sr. CTM) to be part of our Clinical Operations team.   This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The SCTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The SCTM will focus on the management and support of multinational, multicenter, Phase III studies and may assume responsibility for additional studies/indications as applicable. The SCTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

 

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The SCTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.


 

Job Responsibilities

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.
• Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues/risks, escalates as needed and recommends/implements
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review/clean up.
• Coordinate with Lead and Finance to track the financial status against budget.
• Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization; implementation of PI Training, site monitor training, etc.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational

 

Qualifications:

Education

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

 

Experience

• Minimum of 7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is
• Experience working on global teams is desired, Asia-Pacific and EU highly

 

Core Competencies, Knowledge and Skill Requirements 

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials. 

 

Travel Required: Up to 30%
]]> Mon, 09 Mar 2026 00:00:00 EDT 0
This is a hands-on role for a multidisciplinary expert focused on solving the core mechanical challenges at the heart of our next-generation platforms. You will be responsible for concepting, designing, building, and testing novel electro-mechanical, pneumatic, thermal, and fluidic solutions that ensure the ultimate performance, reliability, and longevity of our systems.

The Principal Mechanical Engineer will play a vital role in driving innovation for our next-generation instrumentation. We are looking for someone that exhibits a high degree of motivation, independence, and resourcefulness to help us develop solutions to novel DNA Sequencing and automation challenges in a fast-paced and collaborative environment.

Core Responsibilities
You will lead the end-to-end mechanical design and development of mechanical sub-systems including electro-mechanical, pneumatic, fluidic, and thermal components.
You will collaborate with engineers from other disciplines (electrical, consumables, materials) to define and manage all critical technical interfaces for your module.
You will develop novel mechanisms for automated reagent and flow cell loading, clamping, and sealing, ensuring reliability over repeated use.
You will architect and design thermal control systems, including the specification and integration of heating/cooling elements, sensors, condensation control, and heat management.
You will partner with internal and external simulation experts to guide and validate CFD, thermal, and optical models, using empirical data to refine designs.
You will serve as the primary technical expert for your sub-system during integration, verification, and troubleshooting activities, working directly with the Systems Integration team.
You will lead cross-functional design reviews, driving alignment and resolving technical trade-offs between mechanical design, consumables, materials, and assay requirements.
You will drive the technical execution for sub-systems, manage timelines for your design deliverables, and contribute to the overall project plan.
You will create and maintain all design documentation for your sub-systems, including detailed CAD models, drawings, and specifications.
You will contribute to the technical strategy for the future integrated system, providing data-driven recommendations on architecture and technology choices based on your sub-system's performance.
You will present technical progress, data, and design trade-offs to the broader project team and key stakeholders, clearly articulating the rationale and impact of engineering decisions.

Who You Are: (Required)
You have a PhD in Mechanical Engineering, Bioengineering, or a related discipline with at least 3 years of relevant industry experience; or a Master's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 4 years of relevant industry experience; or a Bachelor's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 7 years+ of relevant industry experience.
You have demonstrated deep, hands-on expertise in the design, development, and testing of complex mechanical, electro-mechanical, and pneumatic systems, preferably for life science or diagnostic instrumentation.
You have demonstrated hands-on expertise in thermal management and the design of precision temperature control systems.
You have experience developing fluidics systems and their interfaces including pumps, valves, tubing, sensors, and material selection.
You possess strong proficiency in 3D CAD software (e.g., SolidWorks) for detailed design and the creation of manufacturing drawings.
You have expertise designing components for a variety of manufacturing processes (e.g., machining, injection molding, 3D printing).
You are a creative and resourceful problem-solver, with the ability to troubleshoot complex issues at the interface of hardware, software, and chemistry.
You are proficient with common machine shop tools, as well as test and measurement equipment; proficient with rapid prototyping technology such as 3D printers, laser cutters, CNC mills/lathes, etc; and
You have a demonstrated level of proficiency with Python, LabVIEW, or similar tools for device control and data acquisition.

Preferred:
You have demonstrated the ability to lead technical projects and mentor junior engineers, providing clear guidance and delegating tasks to achieve project goals.
You have experience using simulation tools (CFD, FEA) to guide design decisions.
You have previously worked on the development of next-generation sequencing (NGS) or other genomics instrumentation.
You have experience working in a regulated product development environment
You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations.
You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.

Pay ranges between 65-80/hr based on experience ]]> Sat, 07 Mar 2026 00:00:00 EST 1 Department: Bioanalytical Sciences (BAS)
Job Title: Sr. Administrative Business Partner
Description:
We are seeking a dynamic and professional individual that can work in a fast-paced environment providing administrative support. The Administrative Business Partner will provide direct support to Directors in BAS groups, including BioAnalytical Sciences Operations, Bioassay, Immunoassay, and Mass Spec. In addition, this individual will provide general administrative support to members of the BAS team and execute on project coordination activities to support day-to-day business portfolio operations.
This position will report into the BAS Business Manager. He/She will collaborate with other administrative business partners, within the department, by providing coverage and work load balance. This individual, when requested by his/her manager, may also collaborate with the other administrative professionals within Development Sciences, and participate in other projects as needed.
The administrative professional must exercise sound business judgment and discretion with sensitive, confidential and proprietary information. This individual is expected to work independently while being a strong team player by being proactive, creative, self-directed, and detail-oriented when managing multiple priorities and complex projects.
Job Responsibilities

• Highly skilled in Google Suite and manage shared team drives and complex gCal scheduling requests with both internal and external stakeholders, potentially across multiple time zones
• Proficient in all available tech meeting platforms including in room technology, video conferences, Google Meets, Zoom and global webcasts
• Support the planning and execution of department-wide staff meetings (e.g. Town Halls, department meetings, etc), meeting logistics including agenda creation/distribution, meeting materials, catering, room set-up, etc.
• Support & ensure attendees are prepared to participate in meetings including AV connection, telephony, Zoom info, etc.
• Send communications on behalf of someone (note: complexity depends upon the person requesting)
• Assist in communications for day-to-day team operations, including changes in policies, processes, department reminders (e.g. handling of gifts, etc.), team agreements
• Ensure that employees are recognized for milestones (anniversaries, weddings, birthdays, etc.) based on department guidelines
• Submit facilities, IT, and Site Service requests
• Manage purchase orders, invoices, payment tracking and vendor maintenance
• Manage distribution lists, print services, office supply process and shipping/receiving
• Manage relationships with internal and external stakeholders, often with a high level of confidentiality required
• Coordinate certain logistics of moves (space management), in close collaboration with BAS Business Manager
• Manage and plan team building events & workshops
• Keep up-to-date on available trainings and organize for team and/or other admins in department
• Process and manage vendor/speaker engagements, contracts and payments, etc.
• Arrange for conference registration, business travel and hotel accommodations, submit business expense reports as needed
• Upon request, may edit and enhance documents including presentations
• Manage the hiring process by scheduling candidate interviews, arranging candidate travel (if applicable), manage all logistics for interview day, and administrative onboarding of new hires
• Manage administrative components and logistics of onboarding (ensure new hires have information for orientation, welcome events, new devices, etc.)
• Manage departmental gSites, Currents, websites, newsletters, etc. (collect content, distribute information, oversee maintenance)
• Assist with managing department documents (electronic and hard copy), such as contracts, memos, including sending out and retrieving off-site storage boxes as needed
• Assist with coordinating CRO visit logistics, including setting up CRO personnel on-site visits, meeting setup, and providing logistic related information to CRO personnel
• May assist in managing the manuscript internal peer review process
• Work with other admins in BAS and the Business Manager to plan BAS events and provide coverage as needed

Required Skills and Qualifications:

• Min 10 years related administrative, operations or project management experience (experience gained in pharmaceutical / biotechnology industry is preferred.)
• Experience working with senior leaders/management
• Ability to handle routine and impromptu assignments with minimal supervision and multitask, prioritize and execute tasks independently. May assist in the coordination of work flow among team members
• Collaborative, initiates and facilitates team development, ensures all relevant or useful information within the team is shared, works with different functions to achieve the best overall outcome
• Ability to handle and exercise judgment and discretion concerning sensitive, confidential and proprietary information
• Demonstrates accuracy and attention to detail of own and other's work, communicates and ensures standards for accuracy and detail within the team
• In depth knowledge of Microsoft Office (Powerpoint, Excel and Word), cSuite Tools (including gMail, gCal, gSheets, gSlides, Trello, Lucidchart, gMeet, ZOOM) and able to provide instruction or training to others as needed
• Familiarity with large, matrixed organization preferred
• BS/BA degree plus 10 years exp

Pay Rate Range: $30-39/hr depending on experience 
]]> Fri, 06 Mar 2026 00:00:00 EST 1
Key Responsibilities
• Responsible for the expansion, maintenance, cryopreservation, and thawing of multiple cell lines. This includes ensuring proper handling of cell lines and preparation of media with complex supplements.
• Collaborate with team members to assess cell culture needs and provide necessary support for ongoing research activities.
• Engage with various functional areas to evaluate cell culture and cell banking needs and deliver materials according to defined timelines.
• Understand quality control procedures to validate cell lines as needed to ensure experimental integrity.
• Maintain accurate, detailed laboratory notebooks and relevant documentation for all laboratory activities.
• Opportunities to contribute to the development and implementation of genetically modified cell lines and in vitro cell-based assays to support various Oncology projects.

Basic Qualifications
• B.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or a related life science field, with a minimum of 3 years of hands-on experience working with cancer cell lines, primary cells, and genetically engineered cell lines.
• Expertise in aseptic technique and mammalian cell culture, including handling multiple cell lines simultaneously and preparing media with complex supplements.
• Excellent organizational skills, attention to detail, and proficiency in record keeping.
• Familiarity with cell culture quality control practices such as mycoplasma testing and cell line authentication.

Preferred Qualifications
• B.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or a related life science field, with a minimum of 6 years of strong hands-on experience in mammalian cell culture in the biopharmaceutical or biotechnology industry.
• Proficiency in using electronic lab notebooks for experiment documentation, inventory management, and workflow execution.
• Experience optimizing and troubleshooting mammalian cell culture systems.
• Exceptional organizational skills with meticulous attention to detail and data integrity.
• Strong written and verbal communication abilities.
• Experience in writing and maintaining standard operating procedures (SOPs)
• Experience with online genetic databases and the ability to advise on integrating relevant phenotypic and genetic information into our cell bank management systems.
• Experience with biology techniques such as viral and non-viral transduction or transfection methods (e.g., lentivirus, retrovirus, lipid-based systems).
• Experience and familiarity with laboratory instruments such as plate readers, cell counters, and automated western blot systems.
• Ability to run basic cell assays and develop cell line banking protocols.
• Adaptability in a fast-paced environment with shifting priorities and timelines.

Pay ranges between 32-39.85/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 This role serves as a strategic partner and operational leader within the Medical Affairs organization, supporting US field initiatives. The position partners with cross-functional teams to drive operational excellence, strategic planning, and project execution to support the US Field Medical Team

Key Responsibilities:
• Lead strategic planning and operational activities across Field Medical Affairs, including development of work plans, project milestones, and resource allocation.
• Provides meeting management support for national MSL team meetings and leadership team meetings
• Utilize data analytics to uncover areas of opportunities with US Field Medical to enhance performance, efficiency and project management, tracking productivity and operational excellence with key performance indicators (KPIs)
• Support execution of field strategies and launch planning where applicable
• Support implementation of CRM system enhancements, design and operationalization
• Facilitate training, onboarding, and development programs for Medical Affairs staff
• Prepare and manage communications, presentations, and leadership updates.

Capabilities:
• Strong project management and strategic planning skills
• Ability to lead cross-functional initiatives and manage external partnerships
• Experience in data analysis and performance tracking
• Knowledge of compliance, regulatory, and legal frameworks in medical operations

Requirements:
• BS required, Masters degree preferred
• Senior Manager: 2+ years experience in Medical Affairs roles; Associate Director: 5+ years experience in Medical Affairs roles
• Proven track record in project leadership and operational excellence.

Pay ranges between 82-89/hr]]> Fri, 06 Mar 2026 00:00:00 EST 1 Play a critical role in the development of new life science technology as a reliability engineer in the R&D group.  Provide hands-on, analytical, and reliability expertise to support engineering programs associated with the development of complex instruments.  Work in a team environment to assess and improve product reliability throughout the design process.  Manage reliability projects by implementing tests, analyzing data, assessing reliability risks, and reporting accurate information to stakeholders.

 

Primary duties include the following:

• Lead and monitor multiple reliability projects.
• Provide reliability risk assessments to cross-functional teams and executive leadership.
• Create and implement test plans to effectively mitigate risks in new product designs.
• Facilitate and direct multidisciplinary discussions to evaluate technical risk through FMEA.
• Leverage internal and external resources to complete reliability test plans.
• Record, organize, and manage large amounts of detailed test data.
• Methodically analyze test data and interpret results for critical reliability decision-making.
• Troubleshoot instrument failures and/or reliability issues as necessary.
• Direct, execute, and document root cause investigations.
• Guide the team to corrective action identification, implementation, and validation.
• Escalate top issues by providing clear, well-structured, high-level updates.
• Provide engineering input for new designs to ensure reliable and robust products.

 

Minimum Qualifications:

Education and Experience:

• Minimum of a Bachelor's degree in engineering or related discipline required.
• Minimum of 5 years of reliability engineering experience or experience performing tests to collect experimental data and performing statistical analyses to interpret results. (2 years may be substituted with advanced degree in engineering or related discipline)
• Knowledge of reliability fundamentals and understanding of reliability analysis (i.e., life predictions, product life modeling, root cause analysis, environmental testing, accelerated testing, etc.)
• Applies technical standards, principles, concepts, and techniques to solve problems.
• Excellent communication skills.
• Willingness to work in BSL2 lab
• Willingness to prepare blood samples for testing (training will be provided).

 

In addition to the above minimum qualifications, the following are considered highly desirable:

• Knowledge of fluidic, optical, and/or electro-mechanical systems.
• Experience with test automation (LabView, Arduino, etc.).
• Experience utilizing FMEA to guide team discussions and priorities.
• Statistical knowledge, especially related to six sigma tools and methodology, design of experiments, and reliability modelling.
• Experience managing large sets of data using data processing tools such as Minitab, MATLAB, JMP, or R.

Fully onsite
Pay $40-50/hr based on experience]]> Thu, 05 Mar 2026 00:00:00 EST 1
Reporting to the the Director of DMPK and this person will have strong experience with Si RNA.  

MAJOR DUTIES AND RESPONSIBILITIES:

• Responsible for scientific quality, technical and operational aspects of the Drug Metabolism/ DMPK/ Bioanalytical group in support of Discovery and Development Project Teams.
• Identifies and keeps pace with evolving/ novel technologies and implementation as appropriate  
• Designs appropriate studies/ endpoints and interprets and disseminates the data to the internal project teams and management.
• Accountable for scientific excellence in Discovery, setting the standard for quality research within the DMPK group.
• Facilitates the transition of candidate compounds from Discovery to Development and coordinates execution of plans with key stakeholders.  
• Maintains productive communications with Chemistry, Biology, and Development colleagues.
• Establishes effective partnerships/relationships through collaboration, expertise in current and future analytical technologies, and seamless transfer of information. Encourages and supports collaboration across departments and takes actions that will increase the likelihood of positive outcomes in Research.

EDUCATION REQUIREMENTS: 

• Ph.D. in Pharmaceutical Sciences with relevant field experience in Bioanalysis, Metabolism and Pharmacokinetics supporting drug discovery and development of SMOLs and Biologics (Protein Therapeutics).

EXPERIENCE REQUIREMENTS: 

• Minimum of 8 years of experience in the above areas in the pharmaceutical industry

]]> Tue, 03 Mar 2026 00:00:00 EST 0 Seeking a talented and highly motivated Senior associate Scientist/Scientist to join our Immuno-oncology group. Our collaborative and interdisciplinary research team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.

The successful candidate is expected to contribute to the discovery, research, and development of novel immunotherapeutic agents to address unmet medical needs of cancer patients. S/he/they will have opportunities for career growth through acquisition of new skills and professional relationships in a fast-paced and resource-rich environment.

Key Responsibilities
• Independently execute in vitro and in vivo immunological assays, with study design, data analysis, and interpretation conducted under scientific guidance to support drug candidate initiation and advancement.
• Proactively evaluate new technologies and develop new assays to accelerate early-stage discovery activities and/or enhance our understanding of disease mechanisms
• Manage multiple projects simultaneously and work cross-functionally with colleagues in the oncology, protein engineering, chemistry, translational medicine, biomarker and clinical groups
• Presents research findings and recommendations to senior staff and contribute to preparation of research reports, manuscripts, INDs, and patent filings

Knowledge, Experience and Skills
• Master's degree with 5+ years of experience, or Bachelor's degree with 8+ years of experience in immunology, immuno-oncology, cell biology, molecular biology, or biochemistry in industry or academia.
•Direct experience in research drug discovery and target identification/validation in oncology or immuno-oncology is highly desirable.
• Solid understanding of fundamental immunology concepts, including innate and adaptive immunity, antigen presentation, cytokine signaling, and immune regulation.
• Proficiency in primary T cell-based functional assays such as activation, proliferation and cytotoxicity.
• Experience in conducting and optimizing cell-based assays, as well as performing studies to assess immune responses in human and animal models (including whole blood, PBMCs, and various primary cell subsets).
• Hands-on experience in general molecular and cell biology methods, including mammalian cell culture, multi-color flow cytometry, western blot, ELISA/Luminex/MSD, and CRISPR technology.
• Highly organized, with demonstrated rigor in documenting experimental design, execution, and data analysis.
• Excellent written and verbal communication skills, with the ability to work effectively in a collaborative, cross-functional environment.

Pay ranges between 50-57/hr based on experience ]]> Tue, 03 Mar 2026 00:00:00 EST 1 SUMMARY/JOB PURPOSE:

Seeking a Temporary Legal Project Manager facilitate high priority projects for the Legal Department and its affiliated groups, reporting to the Senior Director, Legal Operations. This role will have primary responsibility for project management of several legal initiatives.   

CORE ASSIGNMENTS:

• LEAP Program 1H2026: Plan and implement the Legal Department’s continuing education (LEAP) program through June of 2026.  This includes soliciting themes and topics from Legal Leadership, working with outside counsel to provide high quality in-person educational programs on legal topics of interest, and managing the execution of the events. (Execution of the events includes scheduling the presentation with the law firm and participants, reserving conference rooms, serving as Host for the Zoom meeting for remote participants, tracking attendance, ensuring the presenters share Continuing Legal Education reference information for those who need credits, and obtaining any feedback Legal Leadership requests.) 
• Quarterly Legal+ Meetings: Plan and manage the Legal / Compliance / QA Department’s Quarterly Meeting internal presentation programming, which includes specific substantive content which will be included in the meeting organized by the Legal Department Executive Assistant.  The work includes obtaining proposals from Legal Leadership and from others for Legal Leadership’s consideration, collaborating with internal experts who will speak or present on such themes, reserving their time slot in the quarterly meeting schedule, and ensuring quality and consistency of the presentation content through careful review, including screening by the LLT.
• Legal Templates Project Phase 2: Project manage the delivery of a fixed number of legal document templates for cross-functional use across the Legal Department.  A task force will be assigned to agree on language that can be built in the Contract Lifecycle Management System; your role will be to schedule the review, negotiation, and finalization of the language, participate in progress meetings with the participants, schedule the configuration and testing of the templates with the CLM Administrator, and organize the change management plan for the template launches.
• Screens AI Pilot: Project Manage the pilot testing effort of a new software tool that utilizes software to compare incoming contract proposals against internal company standards. 
• Other: project manage other assigned ad hoc projects within the Legal Department,  approved by your supervisor, using LPM methodology.

KEY PROJECT MANAGEMENT ACTIVITIES & EXPECTATIONS

• Scheduling: overall project scheduling, team meeting scheduling, task assignments with deadlines, progress reports.  Overall project management should occur in Microsoft Planner, so that actions can be centrally assigned and progress can be shared through the project plan.
• Minutes/Notes: keep notes of project meetings, including attendees, subjects discussed, decisions reached, and action items assigned (with due dates); share them within Microsoft Teams Channel dedicated to each project.
• Action Item Follow Up/ Task Close Out: intervening with reminders to ensure tasks are completed.
• Escalation: communicate 'stuck' activities to manager and Legal Leadership if risks to schedule appear.
• Status Reports: providing weekly progress reports on activities completed and whether each project remains on schedule.  Includes overall status reports (roll-ups) for your manager and Legal Leadership, and individual status reports for the project teams.
• Project Communications: generally:
  • Microsoft Teams: the content for these projects will be managed in Microsoft Teams channels; light communication can be hosted in the channel chats and/or via email
  • Microsoft Planner: the schedules will be managed through Planner, which can be posted to Teams
  • Outlook:  meetings will be scheduled through Microsoft Outlook, special ticketing requirements through JSM may be required to schedule certain larger training rooms
  • Outlook: Status Reports and other content for Legal Leadership will be distributed by email copy, with links to the main content for reference.

Minimum Requirements:

Education:  No specific degree requirement

Number of years of experience: 5+ years required

Software knowledge/requirements: Microsoft Office, plus Microsoft Planner or similar project management/scheduling software required

Industry background: Previous experience in Law Firms or Legal Departments preferred; Life Sciences experience desirable

Certifications: Project Management Professional (PMP) or Certified Associate in Project Management (CAPM)


 
]]> Tue, 24 Feb 2026 00:00:00 EST 1 About the Role
Join our Biologics Pilot Lab and contribute directly to the development, scaleup, and pilot-scale production of early and late-stage biologic programs. In this role, you will execute downstream purification operations, support upstream activities as needed, and help advance programs that are central to the companies biologics pipeline. This position is ideal for candidates who are hands-on in the lab, collaborative, and excited to work on fast moving development efforts.

Key Responsibilities

Technical & Operational
• Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
• Support upstream operations as needed to ensure seamless end-to-end process execution.
• Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
• Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.

Communication & Collaboration
• Present data, results, and conclusions in group meetings and cross functional discussions.
• Communicate technical information clearly and effectively to colleagues at varying levels.
• Work with a team-oriented, collaborative, and solutions-focused mindset.
• Maintain a strong safety focus in all laboratories and pilot operations.

Required Qualifications
• Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
• Proficiency with AKTA systems and UNICORN programming.
• Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
• Strong verbal communication, technical writing, and documentation skills.
• Ability to work effectively in cross functional teams and in a dynamic environment.
• Self-motivated, organized, and comfortable with scientific problem solving.---

Preferred Qualifications
• Experience in pilot plant operations for biologics in a single-use facility.
• Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles. 

Education
• AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
• BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.

Work Requirements
• This is a 100% onsite role in Foster City, CA.
• Occasional weekend work required to support pilot-scale biologics operations.

Pay ranges between35-41/hr based on experience ]]> Thu, 19 Feb 2026 00:00:00 EST 1
Serve as the primary operational partner to the Associate Director, Curriculum Strategy, Experience, and Design by organizing portfolio data, maintaining lifecycle oversight, and preparing information that supports informed decision making

Ensure learning portfolio components are consistently structured, documented, and aligned with established governance standards, SOPs, and operating principles.

Coordinate internally across learning operations, LMS operations, learning effectiveness, and design teams to maintain portfolio integrity, data accuracy, and system alignment

Maintain lifecycle transparency including content evolution, expiration, retirement, and updates to support compliance, audit readiness, and operational continuity
Support ongoing operational maturity by improving portfolio visibility, consistency, and readiness for future enhancements, measurement, and technology enablement

Pay ranges between 35-43.50/hr based on experience ]]> Wed, 18 Feb 2026 00:00:00 EST 1 The Opportunity:  Senior Manager of Regulatory Affairs

The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
• Correspond and collaborate with RevMed colleagues and departments to achieve alignment.
• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
• Perform regulatory research to inform business strategy. Assess and communicate risks. 
• Assure that there are no significant interruptions to the business due to regulatory compliance issues.
• Collaborates across the organization at all levels, across functional groups, and with executive management.
• Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations.
• Establish collaborative and effective relationships with colleagues in Clinical, Clinical Operations and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.
• Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
• Proven track record of successful submissions within a regulatory environment.
• Exceptionally strong team player with excellent interpersonal and communication skills.
• Detail-oriented with strong organizational skills and high-quality standards.

Preferred Skills:

• Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred.
• Direct experience with IND/NDA filings.

]]> Wed, 18 Feb 2026 00:00:00 EST 0 The Opportunity:  ESR Contract Manager

Revolution Medicines is seeking a highly motivated and detail-oriented individual to manage all aspects of Expanded Sponsored Research (ESR) contracts, including Investigator-Sponsored Trial (IST) agreements. The ESR Contract Manager plays a pivotal role in negotiating contracts and budgets aligned with protocol specifications, ensuring compliance with company regulatory, and fair market value (FMV) standards. The contract manager will be responsible for maintaining tracking systems and overseeing investigator contracts and budgets. Additionally responsible for timely and accurate processing and administration of payments to the sites. This role is an individual contributor with team leadership responsibilities, reporting to the Director, Clinical Site Contracts.

Required Skills, Experience and Education:

• 
  BS/BA degree in related discipline and a minimum of seven years of related experience; or,
  
• 
  Develop clinical trial budgets according to protocol specifications.
  
• 
  Independently manage clinical trial contract/budget negotiations with sites.
  
• 
  Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status.
  
• 
  Review and negotiate investigator-prepared budgets for FMV compliance.
  
• 
  Develop management reports to support budgeting and forecasting.
  
• 
  Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
  
• 
  Help foster good relationships with clinical investigators.
  
• 
  Responsible for reconciliations.
  
• 
  Participate in team meetings.
  
• 
  Ensure compliance with policies and procedures.
  
• 
  Contract amendments, and is responsible for the developing work instructions, internal and external training, managing workload and preparing and monitoring tracking systems.
  

Preferred Skills:

• 
  Strong Excel knowledge required; GrantPlan experience.
  
• 
  Apply strong analytical and business communication skills.
  
• 
  Ability to work effectively in a team/matrix environment.
  
• 
  Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
  
• 
  Oncology experience.
  
• 
  Biotech/pharma experience a plus.
  
• 
  CMS experience.
  
• 
  Smartsheet experience.
  
• 
  Strong organization skills with knowledge in creating/managing spreadsheets. #
  

]]> Tue, 10 Feb 2026 00:00:00 EST 0 The Opportunity:  Senior Manager, Commercial Regulatory Affairs

Seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

• 
  Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.
  
• 
  Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.
  
• 
  Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.
  
• 
  Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.
  
• 
  Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.
  
• 
  Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.
  
• 
  Participate in the development and maintenance of MLR operational objectives, policies, and procedures.
  

Required Skills, Experience and Education:

• 
  Bachelor's Degree in a relevant field with 5+ years relevant experience.
  
• 
  8+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.
  
• 
  Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.
  
• 
  Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.
  
• 
  Track record of influencing cross-functional decisions and operating with sound regulatory judgment.
  
• 
  Excellent communication skills and ability to work collaboratively across teams.
  
• 
  Collaborative and solution-oriented mindset and approach.
  
• 
  Exemplary compliance ethics and high concern for standards.
  
• 
  Advanced degree in a relevant field.
  
• 
  Experience in oncology therapeutic areas.
  
• 
  Experience with product launches.
  

]]> Thu, 05 Feb 2026 00:00:00 EST 0