Job DescriptionThe 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 .
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.
QualificationsBasic 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 , 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 InformationPosition 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: $125,000 - $135,000
- 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
