Lead and support analytical method transfers for large molecule bioassays, ensuring robustness, compliance, and alignment across R&D, QC, and manufacturing sites.
Compensation
Competitive compensation aligned with your knowledge and experience. 3% year-end payment and an annual bonus based on individual and company performance.
Responsibilities
Act as sparring partner for R&D during early assay development
Prepare and execute transfer plans with timelines and milestones
Lead risk/gap assessments and review transfer documentation
Align with stakeholders on method readiness and acceptance criteria
Serve as SME for LM bioanalytical methods
Requirements
Bachelor of Applied Science (BSc) or Master of Science (MSc) in Biochemistry, Biology, Molecular Biology, or related field
Provide technical leadership and project support across Raw Materials, Metals, Lithography, and Advanced Circuits analytical laboratories, accelerating analytical project transfers and improving laboratory processes.
Compensation
The Pay range for this role is $82,600.00 - $129,800.00 Annual
Responsibilities
Lead analytical project and method transfers, including new products, materials, methods, and testing requirements.
Partner with cross‑functional teams to define requirements, manage priorities, resolve technical challenges, and ensure successful project execution.
Drive continuous improvement initiatives that enhance laboratory efficiency, cycle time, data quality, throughput, and reliability.
Use data and structured problem‑solving to optimize workflows, standardize best practices, and deliver sustainable improvements.
Identify and advance future laboratory capabilities, including new instrumentation, automation, digital tools, and analytical technologies.
Provide strategic and technical leadership for GMP analytical activities, managing method lifecycle, quality assurance, and regulatory compliance.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,463.20 to $203,194.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement
Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support
Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments
Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments
Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners
Support QC testing for in-process, final product, and stability samples, including data review/verification, method transfer, documentation, deviations, investigations, and continuous improvement efforts.
Compensation
Summit West - NJ - US: $34.82 - $42.19per hour
Responsibilities
Perform routine testing of in-process, final product, and stability samples
Perform testing for method transfer/validation/verification
Perform data verification, data review and review of GMP documentation for general methods
May perform document revision, project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts
Provide strategic, scientific, and operational leadership for GMP analytical technical operations supporting manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,463.20 to $203,194.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement
Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support
Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments
Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments
Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners
Associate Director Potency Assays - Method Lifecycle Management
Provide analytical expertise for potency assays supporting late-stage and commercial projects across a global network, managing method lifecycle and ensuring GMP compliance.
Responsibilities
Provide technical and analytical expertise in potency assays
Design and perform method validation and transfer strategies
Participate in strategic and technical project discussions
Evaluate and review technical and regulatory submission documents
Act as an analytical SME for regulatory filings
Requirements
University degree in a scientific/life-science-related field
The Senior Scientist is a hands-on technical leader who applies advanced expertise in analytical chemistry and chromatographic separation and analysis to solve complex, high-impact problems.
Responsibilities
Independently designing and executing experiments using advanced analytical techniques: GC/GC/MS, GC/MS, GC/MS/MS, LC/MS, LC/MS/MS, and LC/ELSD, LC/RI, LC/UV
Interting data to drive innovation in product and process development
Mentor and train junior staff
Lead cross-functional collaborations
Contribute to strategic initiatives across the organization
Requirements
PhD in Chemistry
Nice to have: Experience handling hazardous waste
Nice to have: knowledge of hazardous waste classifications
Senior Method Transfer Specialist, Bioassays - Spanish speakingMSD · Boxmeer, Netherlands
Analytical Operations SpecialistQnity · Marlborough, US
Associate Director, QC Analytical Lifecycle ManagementAstraZeneca · Rockville, US
Specialist, QC Analytical, Cell TherapyBristol Myers Squibb · Summit West, US
Associate Director Potency Assays - Method Lifecycle ManagementBioNTech · Mainz, Germany