https://CAREERS.PLANET-PHARMA.COM/ en-us 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 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 ]]> Mon, 09 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 ]]> Mon, 09 Mar 2026 00:00:00 EDT 1
We are seeking an exceptional Senior Executive Assistant to support the external government affairs team. This opportunity requires a polished professional who thrives in a fast-paced, dynamic environment.
More than an administrative partner, the Senior Executive Assistant will serve as a trusted extension of this externally-facing team—anticipating needs, taking initiative, and creating leverage.

What You’ll Do
• Orchestrate complex scheduling, travel, communications, and offsite preparation with accuracy, and efficiency.
• Serve as a trusted liaison of external partners
• Partner in building and sustaining positive environment by supporting offsites, events, and initiatives that strengthen engagement.
• Leveraging digital tools—including emerging technologies like AI—to drive efficiency and unlock new ways of working.
• Draft, review, and refine executive-level communications, presentations, and reports with clarity, accuracy, and professional polish.
• Handle budgeting of group, including management of ARIBA contracts, PO generation, and invoicing.
• Prepare federally required reports.
What You Bring
• 10+ years of experience supporting C-suite or senior executives in complex, global, or high-growth organizations.
• A reputation for being proactive, kind, and highly attuned to anticipating the needs of executives.
• Demonstrated success managing senior leadership teams.
• Exceptional organizational skills with the ability to manage multiple, shifting priorities in high-pressure environments.
• Superior written and verbal communication skills, with executive-level polish.
• Strong problem-solving ability and creativity in approaching challenges.
• Proven fluency with modern digital tools and platforms; comfort guiding others in navigating emerging technologies.
Work Hours/Location: This is a part-time onsite/remote role based at HQ in San Rafael, CA. You will typically work onsite two days, and remote work offered as appropriate – for example, when team is traveling, which can be often.

Why Join Us?
This is a unique opportunity to directly support the externally facing team of a global biotechnology leader, helping drive organizational impact and supporting the mission to bring life-changing therapies to patients around the world. You’ll collaborate with talented colleagues worldwide and play a critical role in enabling the future of an innovative, mission-driven organization.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.]]> Mon, 09 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

]]> Mon, 09 Mar 2026 00:00:00 EDT 1
The primary responsibilities of the Biophysical Assay Research Associate will include performing analytical method development and testing samples using Capillary Electrophoresis, SDS-PAGE, DLS, MALS, AUC, and other analytical tools; contributing to design and performing experiments with supervision as needed; completing assigned tasks within time frames with high quality; maintaining a well-documented record of activities in lab notebook and reports. The position level will commensurate with education and experience level. Additionally, the role includes regularly summarizing and presenting experimental results in lab meetings and responsible for generating reports. This role will be at our South San Francisco location.

Primary Responsibilities
• Conducting experiments to characterize adeno-associated viral nanoparticles for gene therapy products.
• Performing assays for particle/protein/DNA in multiple assays (Capillary Electrophoresis, SDS-PAGE, DLS, Western Blot, Light Obscuration, AUC, RP, SE - HPLC methods, etc.) to assist in evaluation of product characterization, including but not limited to: process change, formulation study, stability study using statistical methods as needed, following SOPs and execute experiments according to guidelines.
• Developing new assays and transfer to QC, Process Development, and Research.
• Developing new analytical tools to characterize adeno associated viral nanoparticles for gene therapy products
• Participating in writing, reviewing, and editing experimental procedures and reports
• Maintaining accurate records of all analytical development activities timely
• Analyzing and determining the applicability of laboratory data to draw conclusions and to make appropriate recommendations

About you

Must Have/Required
• Bachelor of Science with 2+ years of experience working in a pharmaceutical or biotech company and with the requisite years of experience employing the skills listed in the job description (for each level) performing multiple assays for bioproducts.
• Successful experience operating electrophoresis (CE, SDS-PAGE, alkaline gel, etc.), light scattering (DLS, MALS, etc.), UV/Vis spectrophotometry, or other technologies for protein/DNA-based product development.
• Strong knowledge and deep understanding of protein and DNA chemistry.
• Knowledge and proven experience in protein/DNA-based product development and characterization.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP).
• Proficient in Microsoft Office to include Excel, PowerPoint, and Word.
• Experience with recording experiments in electronic lab notebooks.
• Demonstrated verbal and written skills in technical reports and documents.
• Positive, professional self-starter with a passion for science.
• Proven ability to work collaboratively with effective communication in a team environment as well as being an individual contributor.
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

May Have/Preferred
• Direct, hands-on experience with adeno-associated viral nanoparticles.
• Experience operating chromatography methods (HPLC, etc.) and proficient understanding of chromatography software.
• Experience operating general ultracentrifugation methods.
• Experience operating PCR methods.
• Experience in analytical method development and assay transfer.
• Experience in statistical analysis with proficiency in statistical analysis software.]]> Mon, 09 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

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.

]]> Mon, 09 Mar 2026 00:00:00 EDT 0
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

 ]]> Sat, 07 Mar 2026 00:00:00 EST 1
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 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 ]]> Fri, 06 Mar 2026 00:00:00 EST 1
Manager, Accounts Payable:

Manage team members - check in on workload, items requiring attention/escalation, review of responsibilities and project coordination.

Bank Recs - work with GL/Treasury to address and resolve any and/or unreconciled items.

NTT Quality Tracker - attend monthly meetings to review and discuss items reflected on the tracker for BPI; work alongside NTT for issue resolution when necessary

Duplicate Invoice/Payment Report - review monthly findings provided by AP associate for any necessary AP action

Escalated Issues - teams first line of escalation for questions and or problems.

Metrics - review weekly data and perform data analysis for trends, unresolved holds, repeat offenders so as to provide necessary guidance on PO/invoice monitoring in hopes of increased PO requester/buyer involvement to reduce said holds.

Project Management/Involvement - get involved with and initiate projects alongside internal/external stakeholders to create better systems, efficiencies, processes.

Financial Disclosure Requests - review for accuracy prior to submitting to Regulatory team

SOX & Auditor Requests - provide requested information and attend annual meetings to review SOX controls

Backup to Senior AP associate, AP analysts and AP associate when they are OOO/PTO]]> 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
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 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 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
]]> Fri, 06 Mar 2026 00:00:00 EST 1 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%
]]> Fri, 06 Mar 2026 00:00:00 EST 0 Senior Manager, GMP Quality

Seeking a Senior Manager, GMP Quality who will play a key role within Quality Assurance and is responsible for providing leadership and operational support for programs through different phases of development.

Responsibilities:

• 
  Responsible for providing QA support for batch disposition, quality record ownership, and management of QA activities.
  
• 
  Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
  
• 
  Collaborate with internal and external stakeholders and execute quality systems as the QA SME on deviation investigations, CAPA plans, change controls, shelf-life extensions, revisions to documentation, and other Quality processes.
  
• 
  Lead efforts for QA oversight of the manufacture, validation, and disposition of pre-clinical, clinical, and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions.
  
• 
  Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
  
• 
  Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Method Validations, Stability records, Master Batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and perform product dispositions.
  
• 
  QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
  
• 
  Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug product validation requirements.
  
• 
  Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.
  
• 
  Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
  

Required Skills, Experience and Education:

• 
  A Bachelor's degree in a scientific or technical discipline is required.
  
• 
  A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required.
  
• 
  Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs.
  
• 
  Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.
  
• 
  Experience in Inspection Readiness (domestic and ex-US).
  
• 
  Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.
  
• 
  Knowledge of applicable US and Global compliance regulations and industry practices.
  
• 
  Ability to critically evaluate and troubleshoot complex problems with diligence.
  
• 
  Strong teamwork, collaboration, and management skills.
  
• 
  Ability to manage multiple priorities and aggressive timelines.
  
• 
  Highly responsible, self-motivated professional with enthusiasm and passion for the work.
  
• 
  Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
  

Preferred Skills:

• 
  Experience in auditing vendors and suppliers is preferred.
  

]]> Fri, 06 Mar 2026 00:00:00 EST 0
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]]> Thu, 05 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 The Opportunity:  Biospecimen Management Specialist

Playing a critical role as a Biospecimen Management Specialist within Translational Medicine function, the position will be providing sample management support in, developing scope of work for query resolution and sample management, and maintaining effective working relationships with cross-functional teams for clinical trials.

• 
  Provide expertise in sample tracking for clinical trials.
  
• 
  Provide sample management support for clinical trials.
  
• 
  Provide daily operational support for sample shipment while ensuring end-to-end chain of custody.
  
• 
  Work independently on completing all sample related tasks for timely delivery of results.
  

• 
  Work in close collaboration with Translation Medicine Biospecimen Operations Leads and Clinical Operations team.
  
• 
  Provide biomarker sample management plan to key stakeholders.
  
• 
  Perform day-to-day operational management of CROs to ensure timely delivery with a high standard of quality.
  
• 
  Perform sample query resolution and sample management in a timely manner
  
• 
   Assist in sample reconciliation between clinical sites and  central labs.
  
• 
  Provide sample and assay status updates to cross-functional teams.
  
• 
  Manage documentation and tracking of samples in the Company’s systems.
  

Required Skills, Experience and Education:

• 
  Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.
  
• 
  2+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.
  
• 
  A knowledge of RAVE Electronic Data Capture System is highly desirable.
  
• 
  Excellent scientific and business communication skills, strong interpersonal/collaboration skills, and planning skills.
  
• 
  Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
  
• 
  Ability to multi-task and thrive in a fast-paced innovative environment.
  
• 
  A great teammate, who listens effectively and invites response and discussion.
  
• 
  Commitment to Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.
  

Preferred Skills:

• 
  Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.
  
• 
  Experience in using Project Management tools is desirable.
  
• 
  Prior experience in clinical biomarker operation and/or sample management in phase III clinical trials is highly desirable.
  

]]> Thu, 05 Mar 2026 00:00:00 EST 0 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 ]]> Thu, 05 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
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
Laboratory Operations & Equipment Expertise:
Support the setup and launch of the new Process Technologies & Development lab space, including organizing the workspace, assisting with equipment installation and qualification, and ensuring all systems are ready for routine study execution.

Operate, maintain, and troubleshoot a wide range of primary container and analytical laboratory equipment (e.g., leak detection systems, headspace analyzers, optical and particle counting microscopes, microCT scanners, automatic filling equipment, filtration and mixing tanks, balances, etc.)
Independently refine and develop existing laboratory processes and equipment workflows to improve efficiency, robustness, and usability, ensuring that methods and operational practices are easily adoptable by other teams.
Maintain accurate equipment logs, calibration verifications, and support routine instrument readiness for ongoing studies. Ensure the laboratory environment is well-organized, including consumable tracking, chemical inventory, and compliance with the companies safety, quality, and documentation requirements.
Partner with Facilities, Metrology, EH\&S, and cross functional PD teams for seamless lab operations and timely issue resolution.

Scientific Excellence & Continuous Improvement:
Apply sound scientific judgment in planning and troubleshooting studies.
Support method development, lab workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
Drive improvements in lab workflows, equipment utilization, and operational efficiency.
Proactively maintain a culture of cleanliness, organization, and scientific excellence in the lab.

Minimum Qualifications:
Bachelors or Masters degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and lab best practices.
Demonstrated experience designing and executing experiments with attention to detail and scientific rigor.
Strong organizational skills with a track record of maintaining a clean, structured, and efficient laboratory environment.
Excellent communication skills and ability to manage multiple priorities in a fast paced setting.

Preferred Qualifications:
Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
Strong organizational skills with the ability to maintain a clean, structured, and well-run lab environment.
Familiarity with a broad range of laboratory equipment, with hands-on capability in routine operation, troubleshooting, and maintenance.
Familiarity with studies involving container closure integrity (CCI), extractables/leachables, device drug interface, or fill finish operations.
Ability to design and refine lab workflows that improve efficiency, robustness, and usability across teams.
Previous experience working within cross-functional development teams.

Pay ranges between 48-55/hr based on experience ]]> Wed, 25 Feb 2026 00:00:00 EST 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.

]]> Tue, 24 Feb 2026 00:00:00 EST 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]]> Tue, 24 Feb 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
We are seeking a highly motivated Research Associate to join our Target Discovery team focused at the interface of immunotherapy and genomics research. This position will work hands-on with primary human tissues and cutting-edge single-cell technologies to support discovery and validation of novel therapeutic targets. The role offers exposure to the full pipeline – from tissue banking and processing to single cell genomics and experimental validation.  This is an ideal opportunity for a recent graduate seeking industry research experience in immunology, cancer biology, or single-cell genomics.
Key Responsibilities:
• Coordinate, receive, and bank fresh human tissue samples from CROs and external partners.
• Organize, track, and manage tissue samples stored in LN2, ensuring accurate inventory and documentation.
• Perform dissociation of fresh primary human tissues into single-cell suspensions using
enzymatic and/or mechanical methods.
• Execute single-cell RNA-seq workflows, including cell preparation, FACS, and library
preparation.
• Set up, operate, and maintain flow cytometry instruments and cell sorters.
• Maintain and expand cell lines using sterile cell culture techniques
• Perform target antibody screening workflows using flow cytometry, ELISA, Western blotting, and related methods.
• Analyze and document experimental results; contribute to internal datasets and presentations.
• Collaborate with computational and translational scientists to interpret data and support
identification of candidate therapeutic targets.

Qualifications:
• B.S. or M.S. in biological sciences or a related field (immunology, cancer biology, molecular biology, biochemistry, cell biology, and/or bioengineering).
• Highly organized, detail-oriented, and comfortable managing biological samples and associated metadata
• Hands-on experience with wet-lab techniques, such as mammalian cell culture and sterile technique
• Familiary with primary tissue handling, tissue dissociation, or single-cell workflows is a plus
• Familiarity with FACS and/or flow cytometry
• Strong attention to detail and ability to follow complex protocols
• Ability to work independently while contributing to a collaborative team

What You’ll Gain:
• Direct, hands-on experience with primary human tissues, single-cell genomics, and novel therapeutic target biology
• Exposure to real-world therapeutic target discovery and validation in an industry setting
• Mentorship from experienced scientists and opportunities to present your work
• A front-row seat to how cutting-edge biology translates into drug development

 ]]> Wed, 18 Feb 2026 00:00:00 EST 0 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
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

This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. This company will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, the General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Background
The company's Global Finance operations continue to grow rapidly with the overall company and are developing into a leading-edge global finance organization. The company has over $3 billion of annual revenues and operations in 40 plus countries that drive a fast-paced and dynamic team environment, along with operational complexity. The company has ambitious growth plans and has an enthusiastic global team that is eager to deliver world-class accounting and finance services to the company and its stakeholders.
Position Summary
Reporting to the Senior Treasury Manager, this position will support across the Treasury function, including critical treasury operations, FX back office and M&A integration workstreams. This role will require someone with multi-national corporate treasury experience who is highly technical, hands-on, detail oriented, with strong organizational and communication skills. The ideal candidate would be someone knowledgeable across all aspects of corporate treasury function. This role is based in the San Rafael offices, on a hybrid basis.

Bank Infrastructure and Services
• Maintain a best in class worldwide banking infrastructure. Collaborate with the International Treasury team to align banking goals and strategies.
• Ensure high levels of service are provided to corporate business partners and opportunities for efficiencies are identified and evaluated.
• Support best-in-class initiatives around fraud prevention, risk mitigation, straight through processing, governance and global liquidity management.
• Support regulatory compliance, including FBAR and KYC.

SAP Support
• Engage and learn the Company’s SAP MBC treasury workstation, including the Cash Flow Analyzer, payments processes and any new modules.
• Adheres to standards and procedures for project reporting and documentation.
• Performs other related duties as required.

Cash Management, Cash Forecasting and Additional Support
• Support the company’s short-term liquidity forecast utilizing bank systems and SAP.
• Maintain a strong daily cash positioning template. Create and release EFTs as appropriate
• Support the FX Back Office, including wire settlements.
• Monitor intercompany balances, help plan and manage intercompany trade and loan settlements.
• Monitor Treasury operational policies, oversee SOX compliance and support internal and external audit requirements.

Required Skills
• Strong understanding of treasury operations, corporate banking practices
• Experience using treasury workstations (SAP-preferred), risk management systems (FXall, CapellaFX, Clearwater) and various bank and investment portals (CitiDirect, BOA CashPro, JPM Morgan Money)
• Experience managing multiple projects simultaneously
• Desire to share knowledge in a cooperative fashion, to be a team player
• Excellent communication and organizational skills
• Strong work ethic, attention to details, ability and willingness to work effectively independently as well as part of a team
• 7+ years of experience in multi-national Corporate Treasury department
• University degree in Business, Accounting or Finance
• Treasury Qualification (CTP) is a plus



Work Environment/Physical Demands
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Equipment:
Computer skills including Excel, Word, Power Point, G/L and financial reporting systems (Oracle and HFM), Treasury Management Systems, Bank Portals
Contacts:
Interaction with Corporate Accounting, Global Controllership and Regional Finance, FP&A, Bank Partners
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. ]]> Wed, 18 Feb 2026 00:00:00 EST 1 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
Seeking a highly motivated Senior Research Associate to join our Cell Culture Team and support early discovery programs. This is a hands-on laboratory role focused on generating high-quality cellular materials to enable critical go/no-go decisions. The ideal candidate is detail-oriented, collaborative, and thrives in a fast-paced discovery environment.

As the team and function grow, this role can offer meaningful opportunities for professional development and expanded responsibilities.

What you will do:

• 
  Perform routine mammalian cell culture, including expansion, maintenance, cryopreservation, and thawing of multiple cell lines.
  
• 
  Maintain accurate cell line inventory and experimental documentation using Benchling.
  
• 
  Respond to urgent, time-sensitive requests from discovery teams to support key program milestones.
  
• 
  Develop protocols and document experimental workflows and observations with high rigor.
  
• 
  Partner closely with cross-functional teams to assess cell line needs and deliver materials on defined timelines.
  
• 
  Contribute to a culture of transparent, proactive communication across teams.
  
• 
  Identify opportunities to improve efficiency, robustness, and scalability of cell culture workflows.
  

Required Skills, Experience and Education:

• 
  B.S./M.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or related life science field with 3+ years of hands-on mammalian cell culture experience; biopharmaceutical or biotechnology industry experience preferred.
  
• 
  Demonstrated expertise in aseptic technique and mammalian cell culture, including:
  
  • 
    Concurrent handling of multiple cell lines
    
  • 
    Media preparation with complex supplements
    
  • 
    DMSO dilution calculations and cryopreservation best practices
    
• 
  Strong experience optimizing and troubleshooting mammalian cell culture systems.
  
• 
  Familiarity with cell culture quality control practices (e.g., mycoplasma testing, cell line authentication).
  
• 
  Proficiency with electronic lab notebooks (e.g., Benchling) for experiment documentation, inventory management, and workflow execution.
  
• 
  Excellent organizational skills with meticulous attention to detail and data integrity.
  
• 
  Strong written and verbal communication skills
  
• 
  Ability to work independently while collaborating effectively across teams.
  
• 
  Ability to prioritize work, meet deadlines, and remain composed in a dynamic, fast-paced environment.
  
• 
  Familiarity with standard laboratory equipment (microscopes, pipettes, centrifuges, cell counters).
  
• 
  A positive, flexible, and collaborative mindset with a continuous improvement mentality.
  

Preferred Skills:

• 
  Experience working with cancer cell lines, primary cells, or genetically engineered cell lines.
  
• 
  Experience with viral and non-viral transduction or transfection methods (e.g., lentivirus, retrovirus, lipid-based systems).
  
• 
  Hands-on experience with 2D and 3D cell culture systems, including spheroids and/or organoid models.
  
• 
  Exposure to cell-based assay development and downstream applications (e.g., viability, proliferation, reporter assays).
  
• 
  Experience supporting early discovery or translational research programs.
  
• 
  Experience in regulated or semi-regulated laboratory environments with strong documentation standards.
  
• 
  Exposure to automation, high-throughput cell culture, or scale-up workflows.
  

]]> Mon, 02 Feb 2026 00:00:00 EST 0