Senior Scientist, Analytical Development

The Senior Scientist Analytical Development is responsible for designing and developing cell-based bioassays for supporting characterization and potency lot release testing of biologics for client projects and internal product development. The Senior Scientist combines strong technical expertise project leadership and cross-functional collaboration to achieve business objectives while maintaining the highest standards of quality documentation compliance and data integrity.

Senior Scientist Analytical Development Duties Include but are not Limited to the Following:

Bioassay Design Development Qualification and Transfer

• Design develop optimize and qualify cell-based bioassays supporting potency lot release product characterization stability and comparability.
• Additional experience developing neutralizing antibody detection assays is preferred.
• Support assay transfer to GMP labs and other client affiliated sites.
• Develop characterize and maintain assay-ready cell lines and cell banks to support internal product development custom assay programs and client projects.
• Establish and evaluate assay performance attributes including accuracy precision specificity sensitivity linearity robustness reproducibility and suitability for intended use in accordance with applicable ICH and USP guidance including ICH Q6B and USP <1032>.

Technical Documentation Quality and Compliance

• Author review and maintain protocols reports SOPs technical documentation assay development records qualification documentation cell banking records manufacturing-support documents and technology transfer packages to ensure scientific accuracy data integrity and regulatory compliance.
• Maintain accurate records in electronic laboratory notebooks (ELNs) and ensure compliance with internal quality systems documentation practices training requirements and data integrity expectations.

Data Analysis and Scientific Communication

• Analyze interpret and present assay data using appropriate statistical bioassay and relative potency analysis tools including validated or industry-standard software platforms.
• Present scientific findings project updates technical recommendations and assay development strategies to clients internal stakeholders and cross-functional project teams.
• Proficiency with scientific and statistical data analysis tools such as GraphPad Prism JMP PLA SoftMax Pro or similar software.

Scientific Leadership and Cross-Functional Collaboration

• Provide technical guidance scientific mentorship and day-to-day support to junior scientists research associates and cross-functional team members.
• Collaborate with Quality Regulatory Manufacturing Process Development Project Management Business Development and client-facing teams to support project objectives timelines technical alignment and successful program execution.

Product Development Technology Transfer and Continuous Improvement

• Support new product development assay platform expansion technology transfer assay lifecycle management and continuous improvement initiatives.
• Investigate technical issues perform root cause analysis recommend corrective and preventive actions and implement solutions to improve assay performance robustness and reliability.

Additional Requirements and Success Metrics

• Ensure timely delivery of high-quality results that meet client expectations internal quality standards and applicable regulatory requirements.
• Comply with Environmental Health and Safety (EHS) quality documentation training confidentiality and company policies; perform other duties as assigned.

Qualifications :

Basic Minimum Education Qualifications:

• Ph.D. in Cell Biology Immunology Molecular Biology Biochemistry Biotechnology Pharmaceutical Sciences or a related scientific discipline with minimum 5 years of relevant industry experience; or
• M.S. degree in a related scientific field with minimum 8 years of relevant industry experience; or
• B.S. degree in a related scientific field with minimum 12 years of relevant industry experience.

Basic Minimum Work Requirements:

• Strong experience in the development qualification validation troubleshooting and transfer of potency assays for biologics including antibodies recombinant proteins vaccines cell therapies gene therapies and other advanced therapeutic modalities.
• Technical expertise in cell-based bioassays reporter gene assays mechanism-of-action assays neutralizing antibody (NAb) testing ELISA flow cytometry mammalian cell culture relative potency analysis and cell banking workflows.
• Hands-on experience with microplate-based assay platforms fluorescence- and luminescence-based detection technologies automated or semi-automated assay workflows and assay performance optimization.
• Working knowledge of ICH Q6B USP <1032> FDA and EMA expectations GMP/GLP requirements data integrity principles assay qualification and validation expectations and CMC considerations for biologics development.
• Proficiency with scientific and statistical data analysis tools such as GraphPad Prism JMP PLA SoftMax Pro or similar software.
• Experience working in a CRO CDMO biopharmaceutical or contract testing environment.
• Experience developing potency assay strategies for monoclonal antibodies cytokines vaccines cell therapies gene therapies and advanced therapeutic modalities.
• Experience developing or supporting neutralizing antibody detection assays.
• Experience working directly with clients supporting client-facing technical discussions and managing external collaborations.
• Prior mentoring scientific leadership project leadership or project management experience.
• Experience supporting assay transfer into GMP testing environments or working with GMP testing teams.
• Strong technical writing skills with experience authoring and reviewing protocols reports SOPs assay development summaries qualification/validation documents and client-facing technical content.
• Demonstrated ability to translate complex biological analytical and experimental data into clear scientifically sound conclusions and high-quality documentation.
• Excellent problem-solving organizational communication collaboration and presentation skills.
• Ability to manage multiple projects in a fast-paced deadline-driven environment with changing priorities and timelines.
• Strong commitment to quality compliance documentation discipline data integrity and continuous improvement.
• Experience using ELNs controlled document systems and bioassay analysis platforms in a regulated or quality-controlled environment.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

This is a full-time laboratory-based position requiring routine use of mammalian cell culture analytical instrumentation and bioassay platforms. The role requires flexibility to support project timelines client deliverables technology transfer activities and cross-functional collaboration. Candidates must comply with EHS quality documentation training and company policies.

Additional Information :

Position is full-time working Monday - Friday 8:00am - 5:00pm and additional hours as needed. Candidates currently living within a commutable distance of Fremont CA are encouraged to apply.

• Compensation: $125000 - $135000
• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time