https://CAREERS.PLANET-PHARMA.COM/ en-us
Duties:    
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)

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Target PR Range: 43-53/hr DOE
JOB DESCRIPTION
SUMMARY/JOB PURPOSE: Seeking a Staff Accountant/Senior Accountant for a six-month assignment.

The position will support R&D Accrual team with day to day accounting tasks during system Implementation

Job Description:

• Interpret R&D contracts and determine appropriate accrual schedules and/or models
• Update clinical site accrual models based on current patient enrollment data and latest site budgets
• Analyze, review, and examine R&D related invoices and related support to populate R&D accrual accordingly
• Ensure monthly R&D accrual schedule is complete and ready for manager review
• Work closely with accounting on month end and quarter end close processes, including but not limit to accruals, reporting and reconciliations, etc.
• Prepare complex journal entries on monthly/quarterly basis
• Collaborate with internal and external stakeholders and vendors to ensure accuracy and accrual completeness
• Support both external quarterly and annual audits
• Ensure compliance with Company policies and the application of Generally Accepted Accounting Principles (US GAAP)
• Assist in process improvements and system implementations as needed
• Support ad hoc projects as needed

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 The Opportunity:  Clinical Trial Assistant I

This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.

Responsibilities:

• 
  Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
  
• 
  Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
  
• 
  Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
  
• 
  Assist project team(s) with sample management and generate trial progress tracking systems.
  
• 
  Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
  
• 
  Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
  
• 
  Gather investigator and site information to support study start-up, maintenance, and close-out activities.
  
• 
  Assist in contacting investigator sites to provide study specific information.
  
• 
  May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
  
• 
  Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  
• 
  Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
  
• 
  Support other clinical operations activities as appropriate.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree in biological sciences or health-related field required.
  
• 
  1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  
• 
  Has knowledge of GCP ICH Guidelines .
  
• 
  Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
• 
  Excellent written/verbal communication and interpersonal skills.
  
• 
  Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
• 
  Travel may be required (~10%).
  

Preferred Skills:

• 
  Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  
• 
  Oncology experience preferred.
  
• 
  Attention to detail.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 0 The Opportunity:  The Director, Regulatory Affairs – Business Excellence & Execution

The Director, Regulatory Affairs – Business Excellence & Execution supports operational coordination and execution across Global Regulatory Affairs (GRA), enabling alignment, communication, and follow-through between the Sr. Vice President of Regulatory Affairs and the broader regulatory organization.

This role partners closely with the Sr. VP and Regulatory Leadership Team (RegLT) to support department priorities, manage leadership team operations, and coordinate activities across regulatory subfunctions.

The position focuses on keeping priorities moving forward by facilitating cross-functional coordination, maintaining visibility into execution, and ensuring consistent follow-through across GRA. This includes supporting governance forums, enabling communication across functions, and providing insight into progress, risks, and key activities.

Primary Responsibilities

Regulatory Leadership & Governance

• 
  Coordinate RegLT meetings and department-wide offsites, including agenda development, content coordination, and action tracking.
  
• 
  Support follow-through on leadership decisions, ensuring clear ownership and timelines.
  
• 
  Lead the Regulatory Working Group to support alignment of cross-functional priorities, policies, and procedures.
  
• 
  Facilitate discussions, support decision-making, and track execution of agreed actions.
  

Leadership Support & Cross-Functional Coordination

• 
  Support communication and alignment between the Sr. VP of Regulatory Affairs and regulatory subfunctions.
  
• 
  Provide coordination and follow-through on leadership priorities and initiatives.
  
• 
  Coordinate cross-functional regulatory activities, including planning, tracking, and issue escalation as needed.
  
• 
  Liaise across subfunctions to ensure consistent communication and awareness of key activities.
  

Execution Tracking & Reporting

• 
  Maintain visibility into key regulatory activities, deliverables, and commitments across subfunctions.
  
• 
  Develop and maintain dashboards and reports to track progress, risks, and execution gaps.
  
• 
  Provide regular updates to support awareness and decision-making across leadership.
  

Process & Business Excellence

• 
  Support development and refinement of regulatory processes and ways of working.
  
• 
  Coordinate cross-functional input into procedural documentation to ensure consistency and alignment.
  
• 
  Contribute to continuous improvement efforts to enhance efficiency and clarity across GRA.
  

Required Skills, Experience and Education:

• 
  Minimum of 8–12 years of experience in Regulatory Affairs, with experience in business operations, project management, or functional execution within the life sciences industry.
  
• 
  Strong understanding of how Regulatory Science and supporting regulatory subfunctions interact.
  
• 
  Proven ability to manage multiple priorities with strong attention to detail and consistent follow-through.
  
• 
  Experience working in a cross-functional, matrixed environment.
  
• 
  Demonstrated ability to coordinate stakeholders and support execution of complex initiatives.
  
• 
  Strong communication and interpersonal skills, with the ability to engage effectively across all levels, including senior leadership.
  
• 
  Ability to operate independently, driving work forward with minimal direction in a fast-paced environment.
  
• 
  Strong organizational skills and judgment, with the ability to navigate ambiguity.
  

Preferred Skills:

• 
  Experience supporting leadership team operations (e.g., meetings, offsites, action tracking) .
  
• 
  Experience working closely with or supporting senior leadership.
  
• 
  Experience facilitating cross-functional forums or structured discussions.
  
• 
  Experience developing dashboards or reports to track execution and progress.
  
• 
  Familiarity with regulatory systems (e.g., RIMS) and project management tools (e.g., Smartsheet).
  
• 
  Experience contributing to process improvement or operational initiatives.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 0 Job Summary
The Gene Therapy group is seeking to hire a Scientist I (temporary) to become an integral part of the gene therapy drug development effort. We seek candidates who think critically and have the desire and ability to learn new techniques. This position requires adaptability and an ability to perform at a high level in a fast-paced environment. The ideal candidate will leverage their mass spectrometry and chromatography expertise to develop assays in support of gene therapy programs. 

Qualifications

• Ph.D. with 1-3 years, M.S. with 6+ years, or B.S. with 8+ years of industry experience in analytical chemistry, chemical biology, biochemistry or a related field.
• Creativity and the ability to work within an interdisciplinary team to achieve technical and corporate milestones.
• Strong verbal and written communication, critical thinking, and problem-solving skills.

Technical Requirements and Skills:

• Extensive expertise in the development of targeted proteomic assays to support drug product characterization
• Hands-on experience using LC-MS QQQ/QTrap for MRM/SRM analysis (Shimadzu, Agilent, Waters, ExionLC AE, Sciex), including method development, routine instrument maintenance, and troubleshooting.
• Analyze quantitative proteomics data using proteomics analysis software (Skyline, SciexOS) and bioinformatics tools for protein and peptide quantification
• Research literature and external sources to identify new techniques and procedures
• Ideal candidate will have familiarity with ELNs (i.e. Benchling)
• Strong record-keeping and organizational skills.

Nice to Have:

• Working knowledge with recombinant protein downstream purification and characterization
• Familiarity with Olink-based proteomics, MSD, Western blot, metabolomics and unbiased proteomics analysis.

]]> Fri, 10 Apr 2026 00:00:00 EDT 0 Description 
The Senior Manager/ Associate Director, Engagement Platforms and Reporting will support roadmap, implementation and maintenance of technology platforms and measurement reporting for Medical Engagement activities across Global Medical Affairs (GMAF). He/she will support functional Medical Engagement Leads with platform implementation and ongoing maintenance with emphasis on field medical related-systems. Additionally, he/she will implement key measurement framework and reports across breadth of external engagements including field medical, congresses, society engagements, medical education, and other activities.

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

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

 
Additional responsibilities may include:

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

Qualifications (from An Accredited College Or University)

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

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

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

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Key Responsibilities
Fixed Asset Accounting & Reporting
• Manage end to end fixed asset accounting, including additions, disposals, transfers, impairments, and depreciation
• Maintain the fixed asset subledger and ensure alignment with the general ledger
• Perform monthly close activities: journal entries, reconciliations, roll forwards, and variance analysis
• Review and validate asset classifications in accordance with US GAAP and company policy
• Support internal and external audit requests related to fixed assets

CAPEX Accounting & Project Support
• Partner with project managers to monitor capital project spend and ensure proper capitalization vs. expense treatment
• Asset Under Construction (AUC) balances and drive timely project closures
• Assist in forecasting depreciation and CAPEX impacts for FP&A and business partners
• Ensure compliance with capitalization policies and support continuous process improvements

OPEX PO & Accrual Analysis

• Perform monthly OPEX purchase order (PO) reviews to ensure accuracy of commitments, proper coding, and alignment with budget expectations
• Prepare and analyze OPEX accruals, ensuring completeness and accuracy of period end expense recognition
• Partner with budget owners to investigate and explain OPEX variances, providing clear insights into drivers and trends
• Monitor open POs and goods/services receipts to validate timing of expense recognition and identify items requiring cleanup or closure
• Support monthly OPEX reporting packages, including variance commentary and analysis for FP&A and business partners
• Strengthen OPEX-related controls and contribute to process improvements that enhance transparency, accuracy, and efficiency in operating expense management

Controls, Compliance & Process Improvement
• Maintain strong internal controls over fixed asset and CAPEX processes
• Support SOX documentation, testing, and remediation activities
• Identify opportunities to streamline workflows, enhance reporting, and improve data integrity
• Contribute to system enhancements or ERP projects impacting fixed asset accounting
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.

Qualifications
Required
• Bachelor’s degree in accounting, Finance, or related field
• 5+ years of relevant accounting experience, including 3+ years focused on fixed assets and/or CAPEX
• Strong understanding of US GAAP, including capitalization rules and depreciation methodologies
• Advanced Excel skills and experience working with large data sets
• Experience with major ERP systems (SAP, Oracle, NetSuite, or similar)

Preferred
• CPA or CPA eligible
• Experience in biotech, pharma, manufacturing, or other capital-intensive industries
• Familiarity with SOX controls and audit processes
• Experience with project accounting modules or fixed asset subledger systems

Key Competencies
• Strong analytical and problem-solving skills
• High attention to detail and accuracy
• Ability to manage multiple priorities and meet deadlines]]> Thu, 09 Apr 2026 00:00:00 EDT 1
The marketing consultant is a key member of a product marketing team and will contribute to driving growth for the approved indication and/or preparing for entry into new disease areas. The marketing consultant will partner with the marketing team members and support the pull through of key print and digital tactics for HCPs and/or caregivers.

Responsibilities may include the following:
• Work closely with brand team members to develop and develop and roll out promotional materials (e.g., panels, leave behinds, rep triggered emails) to support branded and/or unbranded campaigns
• Partner with brand team members to provide operational support for key brand related activities including speaker programs, advisory boards, conferences and sales meetings
• Work with agency partners and guide the development of key marketing materials
• Partner with the team to develop and shape initiatives which could help generate brand demand
• Financial stewardship: Budgeting, managing the contracting, accrual and reconciliation process, etc.
• This position may require travel, such as attending various brand related events including key conferences, training events, and speaker events. The marketing team is based on on the San Rafael campus (hybrid); however, marketing consultants who wish to work remotely will be considered

Required skills and experience
• Pharma / biotech in-house marketing experience
• Project management experience
• Vendor / agency management experience
• Must be comfortable working in a fast-paced environment
• Demonstrated ability to optimize messages and claims in collaboration with the promotional review team (medical, regulatory, legal)

Preferred skills and experience
• Experience across multiple therapeutic areas; rare-disease experience a plus
• Prior pharma sales experience a plus


Education
• Bachelor's degree required
• Advanced degree (master's or higher) preferred

Required experience

4+ years experience in U.S. biotech / pharma marketing. Experience with the following programs and systems preferred: Veeva PromoMats, MS Word, Excel, Outlook, PowerPoint, Adobe Acrobat, MS Teams. Understanding of U.S. regulatory environment to support development of marketing materials and deliver key brand related initiatives.

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.]]> Thu, 09 Apr 2026 00:00:00 EDT 1
JOB DESCRIPTION

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

RESPONSIBILITIES

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

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

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

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

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

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

Other duties as assigned.

Skills

Required Skills:

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

Experience with biochemical characterization methods is required:

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

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

cIEF (Maurice) experience is highly desirable

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

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

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

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

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

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

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

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

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

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

Desired Skills:

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

Knowledge of biopharmaceutical process development is a plus.

Experience with automation is a plus.

Experience working in a cross-functional environment.

Good understanding of root cause analysis methodology.

Education

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

Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
 ]]> Thu, 09 Apr 2026 00:00:00 EDT 1
This role is highly execution-oriented and requires strong program management discipline, systems fluency (SAP, Ariba, contract lifecycle tools), and the ability to design pragmatic interim processes that evolve into steady-state operating models.

Key Responsibilities
Integration Planning & Program Management

• Design and own the procurement integration roadmap, including Day 1 readiness, interim state, and steady-state transition milestones.

• Develop and maintain detailed timelines of activities, dependencies, and decision points across supplier onboarding, contracting, PO/invoicing, and system cutovers.

• Identify critical path items and risks (e.g., employee wave transitions, invoice approval gaps, supplier ownership changes) and proactively drive mitigation plans.

• Coordinate with the Integration Management Office (IMO) to align procurement activities with broader integration waves and change milestones.

E2E Procurement Process Design
• Design and document end-to-end procurement workflows (Source-to-Contract, Procure-to-Pay) tailored to integration scenarios.

• Create swimlane process maps that clearly define roles and responsibilities across:
o Legacy entity stakeholders
o New parent/company stakeholders
o Procurement
o Finance / FP&A
o Legal / Legal Ops
o AP / Shared Services

• Define differentiated workflows for:
o Existing vs. new suppliers
o Existing vs. new spend
o Expedited / critical supplier scenarios
o Dual-system environments

Cross-Functional Governance & Decision Enablement
• Establish clear decision frameworks for retain / terminate / amend contracts and suppliers.
• Ensure business ownership is explicitly assigned for suppliers, contracts, POs, and invoice approvals at every stage of the integration.
• Facilitate cross-functional alignment sessions to drive timely decisions on:
o Budget approvals
o Spend thresholds and escalation paths
o Contract ownership transitions
o Supplier communication timing and messaging
o Additional identified dependencies

• Act as a neutral facilitator to resolve ambiguity where ownership, authority, or policy interpretation is unclear.

Supplier & Contract Transition Management
• Partner with Procurement, Legal, and business stakeholders to:
o Identify critical suppliers and contracts
o Support contract review, amendment, termination, or novation activities
o Coordinate bulk uploads into contract lifecycle systems
• Oversee supplier communication plans related to acquisition notices, onboarding changes, and billing updates.
• Ensure continuity of supplier performance management during ownership transitions.

Systems & Controls Enablement
• Design and coordinate procurement system strategies during integration, including:
o Interim dual-system operations
o Supplier and PO transition timing
o Controls to prevent payment disruption

• Partner with Finance and AP to define interim approval documentation and audit-ready controls.
• Support reconciliation and reporting requirements across systems during transition periods.

Documentation, Training & Change Enablement
• Produce clear, reusable integration artifacts, including:
o Process overviews and playbooks
o Role-based guidance for business stakeholders
o Approval matrices and escalation models
• Support training for managers, IMO partners, and procurement contractors on new or interim workflows.
• Capture lessons learned and continuously improve integration templates and standards.

Required Qualifications
• 8+ years of experience in procurement, sourcing, finance operations, or transformation roles
• Demonstrated experience leading complex, cross-functional programs (M&A integration experience is required
• Deep understanding of Source-to-Pay / Procure-to-Pay processes
• Hands-on experience with procurement and finance systems (e.g., SAP, Ariba, NetSuite, contract lifecycle tools)
• Strong ability to translate ambiguity into structured plans, workflows, and decisions
• Excellent stakeholder management, facilitation, and communication skills

Success Measures
• Day 1 readiness achieved with no disruption to critical suppliers or payments
• Clear, adopted E2E workflows with documented ownership and approvals
• Timely contract and supplier transition decisions aligned to integration waves
• Reduced operational risk and rework during system cutovers
• Positive stakeholder feedback on clarity, execution, and decision enablement

Working Style & Mindset
• Highly organized, detail-oriented, and comfortable operating in ambiguity
• Pragmatic problem-solver who balances policy adherence with business continuity
• Collaborative leader who builds trust across Procurement, Finance, Legal, and the business
• Continuous improvement mindset with a focus on reusable integration standards

Pay ranges between 88-93/hr based on experience ]]> Thu, 09 Apr 2026 00:00:00 EDT 1 The Opportunity:  Manager, Regulatory Project Management

Seeking a Manager, Regulatory Project Management to support execution of regulatory planning and major submission activities across our development portfolio. This role will serve as a key operational partner and back-up to the Regulatory Planning lead, helping ensure continuity, cross-functional alignment, and disciplined delivery of regulatory milestones. The Manager will play an integral role in supporting complex submissions by translating regulatory strategy into structured, actionable project plans and driving accountability across cross functional contributors. Working closely with Regulatory Science, Regulatory Operations, and cross-functional stakeholders, this individual will enhance visibility into timelines, proactively identify risks, and help enable efficient, high-quality regulatory execution in a dynamic environment.

• 
  Serve as back-up to the Regulatory Planning lead, ensuring continuity of regulatory planning activities and timeline oversight.
  
• 
  Support development and maintenance of integrated global regulatory timelines across programs.
  
• 
  Provide project management support for major submissions, including complex regulatory submission planning and milestone coordination.
  
• 
  Facilitate Global Regulatory Strategy Team meetings, including agenda coordination, minute-taking, action item tracking, and follow-up with functional team members.
  
• 
  Develop and maintain detailed submission delivery plans and milestone trackers.
  
• 
  Monitor progress against commitments and proactively surface risks, dependencies, and resource considerations.
  
• 
  Prepare clear status updates, dashboards, and planning materials for internal stakeholders.
  
• 
  Coordinate with Regulatory Operations to align planning outputs with document readiness and submission execution.
  
• 
  Assist with health authority meeting logistics and cross-functional preparation activities.
  
• 
  Contribute to enhancement of regulatory planning tools, templates, and processes.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree in life sciences or related discipline.
  
• 
  5+ years of experience in regulatory affairs, regulatory operations, or regulatory project management within biotech or pharmaceutical industry.
  
• 
  Experience supporting a major regulatory submission (e.g., NDA, BLA, MAA).
  
• 
  Working knowledge of global regulatory submission processes and lifecycle management.
  
• 
  Demonstrated ability to build and manage detailed project timelines in a cross-functional matrix environment.
  
• 
  Strong meeting facilitation and follow-up skills, with proven ability to drive accountability.
  
• 
  Proficiency with project planning tools (e.g., Smartsheet, MS Project, or similar platforms).
  
• 
  Excellent organizational skills and attention to detail.
  
• 
  Strong written and verbal communication skills.
  

Preferred Skills:

• 
  Experience supporting NDA submissions in oncology or complex development programs.
  
• 
  Familiarity with eCTD structure and regulatory publishing workflows.
  
• 
  Experience with Regulatory Information Management (RIM) systems.
  
• 
  Proficiency in timeline visualization tools (e.g., OnePager, TimelinePro).
  
• 
  PMP certification or formal project management training.
  
• 
  Demonstrated ability to influence cross-functional teams without direct authority.
  

]]> Wed, 08 Apr 2026 00:00:00 EDT 0 Digital Experience is shaping the future of how the company connects with our patients and customers by harnessing the power of digital innovation and human-centered design. As healthcare evolves, we are bold in our approach – leveraging cutting edge AI, advanced digital engagement, end-to-end content management, and omnichannel technologies and operations to create seamless, personalized, and meaningful experiences for our patients and customers. This
is your opportunity to lead transformative change, integrating advanced technology with strategic vision to drive impact at scale. If you are passionate about redefining the healthcare experiences and building something extraordinary, we want you on this journey. Let’s redefine
what’s possible together!

This combined team, in collaboration with key partners, builds solutions to serve Marketing, Customer Engagement, Medical Affairs, Public Affairs & Access (“CMG”), and other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. The team is specifically accountable for:

? Defining omnichannel solutions, shaping engagement strategies, designing,
operationalizing, and producing seamless, consistent & meaningful patient and
customer experiences.
? Accelerating, connecting, and enabling the development of digital solutions that enhance the patient and customer experience across CMG.
? Advancing the mission of seamless, consistent & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront.

Job Summary
The Senior Business Product Manager, Healthcare Professional (Patient) Customer Relationship Management (CRM) drives the development, adoption, and continuous improvement of the Patient CRM Product, as well as core integrated capabilities such as e-detailing, customer insights modules, messaging etc. Partnering with the Business Product Owner, Executive Director - CRM
Suite Leader, and Technical Product Manager, this role defines product roadmaps, gathers user insights, and drives feature rollouts.
This role is closely integrated with commercial, medical, and other cross-functional teams that leverage CRM to support both digital and in-person customer engagement. Through these deep, wide-ranging connections, the individual in this role will develop a strong understanding of how
CRM strategies and capabilities shape customer experiences, contribute to business outcomes, and empower CRM end-users to deliver meaningful impact.

Key Responsibilities
? Partner with the Business Product Owner and/or Executive Director - CRM Suite Leader to support the creation of digital-forward healthcare provider customer relationship (Patient CRM) product roadmaps, including experience, features, timelines, and dependencies.
? Partner with Technical Product Manager to drive the development and improvement of
Patient CRM product or specific product features, ensuring alignment with the overall Patient CRM product vision.
? Help evangelize the role of product(s) in achieving enterprise objectives, communicating their value proposition and roadmap(s) to senior leaders and organization-wide
stakeholders.
? Act as point of contact for business feedback, recommendations, & user requests for enhancements to the Patient CRM product.
? Collaborate with the Technical Product Manager to align business outcomes with technical feasibility, ensuring the Patient CRM product delivers both business value and technical performance.
? Oversee business process & user insights collection through User Acceptance Testing
(UAT) to ensure the successful implementation of new features and capabilities.
? Support the rollout of new features across new and existing users.
? Collaborate with Business Product Owner / Executive Director - CRM Suite Leader to establish business standards & templates and ensure pull-through.
? Drive definition of business requirements for Patient CRM product capabilities and features and non-functional performance requirements, leveraging GNE and industry standards.
? Drive experimentation to enhance Patient CRM product offerings, in line with the overall business learning agenda.
? Coordinate with business stakeholders, IT, and cross-functional enterprise product team partners to align on the product roadmap, fostering cohesive collaboration and unified efforts toward shared goals.
? Collaborate with cross-functional teams and IT partners to ensure successful Patient CRM
product integration and execution.
? Closely partner with Customer Experience professionals to ensure Patient CRM product experience meets the expectations of its end-user product community.
? Understand customer engagement trends and technologies in the pharmaceutical industry. Track market shift and emerging technologies to inform CRM strategy and
roadmap development.
? Comply with all laws, regulations and policies that govern the conduct of  activities.
? Ensure Patient CRM product features align with compliance, privacy, and regulatory standards while supporting effective field force engagement.
? Collaborate with FieldSales, Medical, and Marketing teams to define and prioritize functionality that supports timely and personalized Patient interactions.

Who You Are
Minimum Candidate Qualifications & Experience
? Bachelor’s degree in business, technology, operations, science, marketing, or a related field.
? 7 years of experience, with 5 years in product management, digital product operations, or equivalent experience.
? Experience with sole ownership of tactics or product components, demonstrating the ability to articulate business problems, identify solutions, and drive execution from strategy through implementation.
? Demonstrated ability to develop and execute product roadmaps, including feature planning, timelines, and dependencies.
? Experience with User Acceptance Testing (UAT) and rolling out new features across a variety of user bases.
? Proven success in aligning stakeholders and collaborating with cross-functional teams to deliver seamless product integration.
? Strong analytical and problem-solving skills, with experience driving experimentation and optimization.
? Exceptional communication and presentation skills, with the ability to evangelize product vision and value across all levels of an organization.
? Proven ability to adapt and navigate ambiguous or evolving environments.
Additional Desired Candidate Qualifications & Experience
? Advanced degree, or equivalent experience (e.g., MBA or related graduate-level qualification).
? Experience in healthcare, pharmaceutical, or highly regulated industries.?
Ability to innovate and foster experimentation to improve product capabilities.
? Experience in leading or managing enterprise CRM platforms (e.g., Veeva, Salesforce) within life sciences or healthcare industries.
? Strong understanding of customer engagement strategies and omnichannel orchestration tailored to Patients.

Location
? This position is based in South San Francisco, CA

Pay rnages between 90-07/hr based on experoence ]]> Wed, 08 Apr 2026 00:00:00 EDT 1 The Opportunity:   Commercialization Contracts Operations Senior Manager

The Commercialization Contracts Operations Senior Manager is essential to execution and achievement of goals and objectives across the Commercialization Function (including Medical Affairs, US Commercial, and Global Commercial functions) at Revolution Medicines.   This role requires strong process management and execution, compliance management, cross functional and vendor collaboration, process optimization, the ability to thrive in ambiguity, and a passion to build and optimize critical business processes. This role will work independently across functions and teams as a trusted partner to proactively manage the efficient tracking, execution and management of Commercialization contracts.

• 
  Execute and manage a growing large volume and variety of contracts (SOWs, CDAs, MSAs) through collaboration with Legal, Contracts and Compliance teams and Business Contract owners with minimal oversight.
  
• 
  Ensure efficiency and compliance of all contracts with company policies, legal requirements, and industry regulations.
  
• 
  Provide training and guidance to new business contract owners on contracting obligations and processes to ensure adherence to legal and compliance standards.
  
• 
  Monitor contract lifecycles, including renewals, amendments, and terminations to ensure timely and compliant management.
  
• 
  Be the liaison and point of contact for business contract owners and vendor/agency inquiries related to contracting and payment in partnership with legal, finance, and procurement. Manage timely and proactive communications with stakeholders.
  
• 
  Leverage understanding of business needs to create prioritization framework and resolve competing urgent business priorities.
  
• 
  Maintain contract management system and tracker to manage and prioritize the volume to ensure timely execution and follow through of fully executed contracts to POs.
  
• 
  Set a vision and plan for process optimization and work with stakeholders across business, legal, contracts & compliance and finance functions to drive enhancement efforts.
  
• 
  Work closely with Commercial Development Operations and Medical Excellence Operations team members to address business needs while optimize contracts administration.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree required with 5+ years of relevant experience in contracts administrative and operations role (procurement, contract management, or purchasing departments) pharmaceuticals or biopharma industry.
  
• 
  Track record of being a collaborative team player and business partner, building positive partnerships and adaptive to meet the needs of a growing business.
  
• 
  Strong critical thinker and problem solver with proactive mindset to build and manage processes and systems that drive accountability and results.
  
• 
  Demonstrated ability to influence management and key business partners without authority.
  
• 
  Excellent organizational skills, ability to multi-task, and prioritize effectively to deliver results within reasonably established timelines.
  
• 
  Strong interpersonal skills including verbal and written communication and represent company and embodies our corporate values.
  
• 
  Proficient in Powerpoint, Excel, Word, and variety of project management (ie, smartsheets) and communication and administrative platforms (ie, Teams, contracts management system, etc).
  

Preferred Skills:

• 
  Targeted Oncology product experience preferred.
  

• 
  Prior experience working in a fast-paced, matrixed biotech or pharmaceutical environment.
  
• 
  Familiarity with emerging digital tools for Medical Affairs and Commercial functions.
  

]]> Wed, 08 Apr 2026 00:00:00 EDT 0 The Opportunity:  Food & Beverage Coordinator

Seeking a highly organized and service-oriented Food & Beverage Coordinator to oversee café and break room operations across our headquarters. Reporting to the Senior Director, Food & Beverage, Events, this onsite role plays a critical part in maintaining quality, cleanliness, compliance, and overall employee experience within our food and beverage spaces.

This role requires strong operational discipline, vendor coordination, and a proactive approach to maintaining high hospitality standards aligned with RevMed’s culture.

Key Responsibilities

Café Operations Management

• 
  Oversee daily café operations, ensuring cleanliness, stocking, organization, and presentation standards are consistently met.
  
• 
  Coordinate café setup and breakdown for daily service and special events.
  
• 
  Submit and track work orders for equipment or facility-related issues.
  
• 
  Ensure proper cleaning, preventative maintenance, and operational readiness of café equipment.
  
• 
  Partner with Facilities and vendors to resolve equipment issues efficiently.
  

Break Room Management

• 
  Maintain cleanliness, organization, and labeling standards across all break rooms.
  
• 
  Oversee day porter activities to ensure consistent replenishment and upkeep.
  
• 
  Ensure food safety standards are upheld, including proper labeling and storage practices.
  
• 
  Support branding and visual consistency across café and break room spaces in alignment with company standards.
  

Vendor Management & Budget Tracking

• 
  Maintain productive working relationships with café, snack, beverage, and service vendors.
  
• 
  Monitor vendor performance to ensure service quality, cleanliness, and compliance with standards.
  
• 
  Track expenses and support reporting to ensure operations remain within approved budget parameters.
  
• 
  Identify cost efficiencies and opportunities for operational improvement.
  

EH&S Coordination & Compliance

• 
  Partner with Environmental Health & Safety (EH&S) to ensure all café and break room operations meet safety and sustainability standards.
  
• 
  Support sustainability initiatives, including waste reduction and environmentally responsible practices.
  
• 
  Ensure compliance with all health department regulations, permitting requirements, and inspection readiness.
  
• 
  Maintain documentation and coordinate renewals for required health department permits.
  

Quality Control & Employee Experience

• 
  Uphold high quality standards across food presentation, cleanliness, service levels, and operational execution.
  
• 
  Support feedback mechanisms to continuously improve food and beverage spaces.
  
• 
  Contribute to creating an inclusive, comfortable, and welcoming environment for all employees.
  

Required Skills, Experience and Education:

• 
  3+ years of experience in food & beverage operations, hospitality, or related field.
  
• 
  Strong understanding of food safety, sanitation, and health department compliance standards.
  
• 
  Experience coordinating vendors and service providers in a corporate or high-volume environment.
  
• 
  Strong organizational and systems skills with attention to detail.
  
• 
  Demonstrated ability to manage multiple priorities in a fast-paced setting.
  
• 
  Effective communication and collaboration skills across diverse stakeholder groups.
  
• 
  Proficiency in Microsoft Office Suite (Outlook, Word, Excel).
  

Preferred Skills:

• 
  Experience in a corporate, biotech, or high-growth environment.
  
• 
  Familiarity with work order systems and basic facilities coordination.
  
• 
  Bilingual (Spanish/English) a plus.
  

]]> Tue, 07 Apr 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 ]]> Fri, 03 Apr 2026 00:00:00 EDT 1
The Opportunity:

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

Who You Are:

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

Pay Rate Range: $25-32/hr depending on experience ]]> Fri, 03 Apr 2026 00:00:00 EDT 1
AP Email Inbox
•       Wholly owns AP inbox and reviews each email thoroughly
•       Respond to all general inquiries and only delegate emails to the respective analyst if:
•       The email is a response in a thread between the sender and analyst
•       The email is a complex inquiry that requires a higher-level response

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

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

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

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

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

 ]]> Thu, 02 Apr 2026 00:00:00 EDT 1
Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.

This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area.  Support with troubleshooting to equipment.

Duties & Responsibilities:

• Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine.  This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage
• Assists with the equipment changeover
• Assists with minor equipment repairs/adjustments
• Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues
• Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
• Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements
• Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required.
• Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
• Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations
• Movement of product and components within the assembly and packaging area
• Transfer product, components and equipment within the CNC area.
• Communication and hand-off to relief personnel during shift change as appropriate
• Maintains production areas according to predefined standards (5s)
• Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately

Skills
Skill Requirements:

• Basic reading, writing and understanding of English
• Read and follow Standard Operating Procedures (SOP)
• Basic math calculations (addition, subtraction, multiplication, division)
• Perform documentation according to Good Documentation Practices (GDP)
• Basic computer skills - write & send e-mail communications, utilize Microsoft office programs (Outlook, Internet Explore/Edge)

Education Requirements:

• High School degree plus minimum one (1) year work experience in GMP regulated industry
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred 

Pay Rate: $20/hr 

 ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Pay 38-42/hr depending on experience

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

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

Education
• Prior experience]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Senior Research Associate – Formulation & Analytical Support

Position Summary
We are seeking a highly skilled Senior Research Associate to provide formulation and analytical support for oligonucleotide based therapeutics across in vitro and in vivo studies. This individual will work both independently and collaboratively to ensure high quality dosing solutions, execute stability testing, support analytical workflows, and contribute to nonclinical and clinical development programs.

Key Responsibilities
Formulation & Dosing Support
• Independently and collaboratively prepare, formulate, and quality check dosing solutions for a range of in vitro and in vivo studies
• Perform formulation stability studies and define appropriate short and long term storage conditions
• Support formulation strategies for oligonucleotides across different delivery and study paradigms

Analytical & Technical Support
• Execute analytical assays to support formulation and quality assessment, including UV, LC MS, and osmolality measurements
• Perform quantitative data analysis across multiple experiments, including basic statistical and graphical analysis
• Proactively troubleshoot technical issues and recommend corrective actions to ensure data quality and project continuity

Innovation & Capability Building
• Develop new techniques or introduce new technologies to enhance the group’s formulation and analytical capabilities
• Contribute to continuous improvement of laboratory workflows and experimental approaches

Documentation & Communication
• Maintain accurate and thorough laboratory notebook records in compliance with data integrity standards
• Prepare SOPs, technical reports, and documentation to support nonclinical and clinical programs, including regulatory submissions
• Present data and actively participate in group meetings, department meetings, and Early Development team meetings

Laboratory Operations
• Share responsibility for laboratory management duties, including equipment readiness, inventory, and general lab organization

Required Skills & Experience
• Good understanding of oligonucleotide therapeutics, formulation approaches, and stability testing
• Hands on experience with analytical techniques such as UV spectroscopy, LC MS, and osmolality measurements
• Ability to perform quantitative analysis across studies with minimal supervision
• Demonstrated ability to work independently while contributing effectively within cross functional teams
• Strong problem solving skills and attention to detail

Education & Qualifications
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field with 6+ years of relevant experience, or
• Master’s degree with 4+ years of relevant experience]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Will lead the financial planning and analytics for the company and is instrumental in establishing and driving financial processes. A forward thinker that understands the strategic directions of Finance Leadership and anticipate implications/impacts.

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

Requirements: 
Bachelor's degree in accounting or equivalent
Minimum of 7 years of progressive finance, accounting, and/or financial planning and analysis experience
Experience in early-stage life science companies
Data driven with strong analytical and critical thinking skill
Ability to manage highly confidential material in an appropriate manner
Excellent verbal and written communication skills, with ability to articulate financial results
Self-directed and able to work well and communicate effectively in a team environment. Hands on and able to work with minimal supervision. Ability to balance multiple deadlines and deliverables.
Exceptional interpersonal soft skills and ability to establish strong rapport and partnerships at all levels of the organization
Experienced user with knowledge of ERP, BI and automated planning systems
Proficiency in Microsoft Project
Previous experience developing financial operating policies and procedures Advanced level of proficiency with Excel, with strong financial modeling skills ]]> Wed, 01 Apr 2026 00:00:00 EDT 0

Independently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up.

Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring.

Monitors and controls weights, flows, volumes, temperatures, pressure, and pH.

Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations

in order to facilitate continuous process improvement.

Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations.

All training will be conducted with an emphasis on safety and completion of operations in a timely manner.

Collaborates within team and department in order to follow best practices and meet department goals.

Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement. Skills:    

• Experience working with established GMP procedures and bulk manufacturing is a plus.
• Technical knowledge of manufacturing systems, methods and procedures.
• Understanding of purification/cell culture processes.
• Possess effective troubleshooting skills with equipment and/or process.

Education:    

• Preferred, associates degree with (1) year closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment

Pay Rate Range: $20-26/hr depending on experience 
 ]]> Tue, 31 Mar 2026 00:00:00 EDT 1 SUMMARY/JOB PURPOSE:

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

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

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

 

SUPERVISORY RESPONSIBILITIES:

None

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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

 

Experience/The ideal for Successful Entry into the Job:

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

 

Knowledge/Skills:

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

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

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

]]> Tue, 31 Mar 2026 00:00:00 EDT 1

• Design and execute preclinical in vivo studies in collaboration with discovery and data scientists, develop timelines and action plans to meet company goals.
• Choose appropriate in vivo models and develop protocols with relevant endpoints for evaluating the mechanism of action, efficacy, and safety of therapeutic candidates.
• Perform hands-on in vivo experiments, including orthotopic tumor cell implantation, IV, IP and SC injections, in vivo imaging, and animal welfare monitoring.
• Perform biological sample collection and processing, MACS/FACS cell sorting, immune cell profiling using multicolor flow cytometry, immunogenicity testing using ELISA and ELISPOT, and cell-based functional assays.
• Generate, document, analyze and interpret experimental data to support critical decisions.
• Manage external laboratories and partners.

Required Skills & Qualifications

• • PhD in Life Sciences with specialization in oncology or immunology.
  • At least 3 years of hands-on experience working with murine tumor models in an
  • industry and/or academic setting.
  • Demonstrated independent ability to design, execute and interpret experimental data.
  • Demonstrated experience in in vivo procedures, such as rodent surgery and IV dosing.
  • Experience with tissue handling and processing, cell sorting, multi-color flow cytometry and cytokine profiling, experience with IHC and ISH is a plus
  • Proficiency in mammalian cell and tissue culture.
  • Detail-oriented, with strong organizational and record-keeping skills.
  • Excellent communication skills and ability to collaborate effectively in a cross-functional team.
  • Experience working in a GLP or regulatory-compliant environment is a plus.

  ]]> Mon, 30 Mar 2026 00:00:00 EDT 0
TECHNICAL SKILLS
Must Have

• Advanced Excel
• Experience with SAP

Nice To Have

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

Key Responsibilities:

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

 

Education & Experience:

Bachelor’s degree in Data Analytics, Business Administration, Public Health, or related field with 1-2 years of relevant experience
]]> Fri, 27 Mar 2026 00:00:00 EDT 1 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 ]]> Fri, 27 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

]]> Thu, 26 Mar 2026 00:00:00 EDT 0
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

]]> Thu, 26 Mar 2026 00:00:00 EDT 0 The Opportunity:  Clinical Pharmacology QC Lead

We are seeking an experienced Temporary Clinical Pharmacology QC Lead to support quality control review of clinical pharmacology submission documents and regulatory responses for oncology programs in late-stage development. This role will ensure scientific accuracy, cross-document consistency and high-quality submission-ready documentation aligned with regulatory expectations and internal standards, supporting timely responses to regulatory agencies.


Required Skills, Experience and Education:

• Advanced degree (MS, Pharm D, Ph.D, MD or equivalent) in life sciences, pharmacy or related field.
• Strong experience in NDA submissions, Clinical Pharmacology and/or clinical documents.
• Demonstrated expertise in QC of regulatory documents
• Strong understanding of ICH guidelines, CTD format and FDA/EMA regulatory processes.
• Excellent attention to detail and ability to work under tight timelines.
• Strong cross-functional communication and issue resolution skills.

Preferred Skills:

• Oncology drug development experience
• Experience supporting FDA information requests

Duration & Commitment:

• Contract position 6 months+
• Remote flexibility possible but candidates will be working onsite at HQ in Redwood City

]]> Wed, 25 Mar 2026 00:00:00 EDT 0 The Research Strategy, Innovation & Portfolio Management group is seeking a talented and highly motivated project manager to manage coordination and progression of scientific research projects in a highly collaborative environment and cross-functional matrix. The candidate will efficiently interact with multiple stakeholders representing multiple functions within the company to drive research projects forward to clinical development.

Essential Responsibilities
• Responsible for starting up or managing the research-based development subteams.
• May help manage teams that are preparing to present their molecule at governance meeting for clinical development.
• Experience working effectively with cross-functional project teams to build and develop the team, diagnose team health and taking action to address team issues.
• Ability to organize new cross-functional project teams, define objectives and scope, identify tasks and milestones, build project schedules, identify resource needs, track execution to schedule, and manage risks.
• Experience and ability in successfully managing multiple cross-functional tasks simultaneously.

Knowledge, Experience and Skills:
• Bachelors degree with 7+ years, MS degree with 5+ years of relevant experience, which includes experience in the pharmaceutical industry as a functional area scientist or project manager.
• Direct experience or strong foundation in drug development process is preferred.
• Experience should include participation in cross-functional project team activities.
• Self-motivated, resourceful, high technical competence and process-oriented.
• Clear and effective communication.
• Ability to work both collaboratively and independently.
• Strong proficiency with Microsoft Office tools (Outlook, Excel, PowerPoint, Word, and Teams) and Zoom.
• Must be on site at Foster City office at least 3 days per week

Pay Range: 68-73/hr based on experience ]]> Wed, 25 Mar 2026 00:00:00 EDT 1 Duties

• Accurately picks (using RF gun), packs, stages, scales, and loads customer orders for external/internal movement and prepares all pertinent documentation.
• Monitors and maintains an adequate supply of operating supplies and informs Coach when supplies need to be ordered.
• Maintains / back fills their respective areas keeping the supplies available.
• Performs clean up and light maintenance duties to maintain a high standard of housekeeping.
• Drives housekeeping efforts in preparation of internal and external audits.
• Actively participates in and completes all company training programs for Work Instructions (WI), Standard Operating Procedures (SOP), Company Policies, and Safety programs demonstrating learned knowledge on a daily basis.
• Actively participates in all Company and Departmental meetings, Performance Centers, etc.
• Performs cycle counts on a daily basis for their assigned area using RF gun and assists in reconciling discrepancies with Inventory Control.

Skills

Required:

• Ability to learn and apply all relevant WIs, SOPs, and other regulatory requirements.
• Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
• Ability to effectively communicate both verbally and in writing to peers and management.
• Must have reliable transportation as position requires working at warehousing facilities located at multiple sites.
• Ability to use computers to perform a variety of data-entry transactions, perform RF transactions and to retrieve information (procedures; safety, employment, and other information using a calculator.
• Demonstrated ability to perform basic math functions using a calculator (add, subtract, multiply, divide, rounding, etc.).
• Demonstrated high level of personal motivation and initiative and be able to work independently to complete daily tasks assigned.
• Ability to adapt and be flexible with daily work assignment changes as well as a continuously-improving work environment.
• Ability and willingness to maintain accurate and factual hard-copy and electronic records.
• Demonstrated ability and willingness to work and participate effectively in a team environment.
• Operate warehouse industrial material handling equipment as required including Pallet Jacks, Pallet Transfer, Shrink Bundler, Strapping Machines, Shrink Wrapper, Pallet Scales, Conveyor, etc.
• Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions.
• Attention to detail, safety, quality and customer requirements.

Preferred: Familiarity with MS Office products (specifically Word, Outlook, and Excel) and SAP or equivalent systems.

PHYSICAL DEMANDS

• Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds with assistance.

Education

• High School diploma or GED
• 2 years GMP warehouse experience

Pay Rate Range: $20-27/hr depending on experience ]]> Tue, 24 Mar 2026 00:00:00 EDT 1
Essential Duties and Job Functions:
• Support the lead training manager by managing assigned components of training initiatives (i.e. planning, execution and follow up) to ensure timelines, quality and objectives are met.
• Lead and collaborate on the development and implementation of knowledge/skill-based training focused on ensuring success through therapeutic disease state and product knowledge for commercial field sales
• Develops and executes training with a specific focus on our new hire program Accelerate as well as account management skills, product knowledge, new promotional campaigns, product launches, communication skills, selling skills, phased trainings, sales meeting training workshops, ongoing learning sustainment programs & other as needed field sales.
• Collaborates with and supports relevant internal departments, including Marketing, Commercial (Field Sales, National Accounts, Regional Trainers), Commercial Operations, Global L&D, Medical Information, Legal, Business Conduct and Regulatory to develop appropriate training.
• Collaborates with internal customers including Compliance/Legal, Marketing and Medical Information to ensure training materials and workshops are current, effective and compliant with regulatory guidelines.
• Partners with external vendors to design curricula or programs and planning of instructional methods and materials using adult learning principles.
• Effectively prepares for instruction by conducting needs assessments, identifying targeted participant characteristics, and soliciting cross-functional feedback before finalizing design and strategy.
• Offers solutions for bridging gaps between current organizational capabilities and needs.
• Helps ensure readiness of the organization for training deployment including identifying key stakeholders and determining their needs in advance, in order to deliver high quality and effective programming.
• Analyzes the characteristics of existing technologies and their use in instructional design.
• Partners with subject matter experts and key stakeholders to identify training needs, improve training solutions and lead change initiative implementation.
• Monitors and maintains alignment with Commercial groups strategic training plan while balancing short-term and long-term business goals.
• Manages budget aligned with both the development of training resources and / or POA / Sales Meetings

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

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

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

Pay ranges between 70-73/hr ]]> Fri, 20 Mar 2026 00:00:00 EDT 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]]> Fri, 20 Mar 2026 00:00:00 EDT 1 The Opportunity:   Senior Clinical Program Manager, Clinical Operations Compliance & Training

This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• 
  Support Clinical Operations with GCP guidance and best industry practices.
  
• 
  Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
  
• 
  Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle.
  
• 
  Support Clinical Operations Inspection Readiness activities.
  
• 
  Contribute to Clinical Operations training programs to deliver standards, GCP, and regulatory requirements.
  
• 
  Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses.
  
• 
  Communicate deliverable status/issues, and problem solve to ensure functional goals are met.
  
• 
  Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
  
• 
  Participate in other Clinical Operations Compliance & Training activities as assigned.
  

Required Skills, Experience and Education:

• 
  RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
  
• 
  10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industryor  Clinical Research-related experience.
  
• 
  Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices.
  
• 
  Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.
  
• 
  Experience with development and monitoring of oversight activities.
  
• 
  Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
• 
  Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
  
• 
  Excellent written/verbal communication and interpersonal skills.
  
• 
  High sense of priority and commitment to excellence in the successful execution of deliverables.
  
• 
  Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
  
• 
  Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
• 
  Travel may be required (~25%).
  

Preferred Skills:

• 
  Oncology experience, early and/or late stage.
  
• 
  Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.
  

]]> Thu, 19 Mar 2026 00:00:00 EDT 0
Duties
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment. • The use of personal protective equipment will be required.
• Requires various shift based work and off hours.

Skills
• Strong communication skills—verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions

Education
-Bachelor’s degree in science related area or engineering
-Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry ]]> Wed, 18 Mar 2026 00:00:00 EDT 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 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