Senior Scientist, Analytical Development

About the Role

Eurofins Scientific is an international life sciences company providing analytical testing services to ensure the safety, authenticity, and accuracy of products across multiple industries. The Senior Scientist, Analytical Development will design and develop cell-based bioassays to support characterization and potency lot release testing of biologics for client projects and internal product development. This role combines technical expertise, project leadership, and cross-functional collaboration to maintain high standards of quality, documentation, compliance, and data integrity.

Responsibilities

• Design, develop, optimize, and qualify cell-based bioassays supporting potency, lot release, product characterization, stability, and comparability. Experience with 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 for internal product development, custom assay programs, and client projects.
• Establish and evaluate assay performance attributes (accuracy, precision, specificity, sensitivity, linearity, robustness, reproducibility) in accordance with ICH and USP guidance, including ICH Q6B and USP.
• Author, review, and maintain protocols, reports, SOPs, technical documentation, assay development records, qualification documentation, cell banking records, and technology transfer packages to ensure scientific accuracy and regulatory compliance.
• Maintain accurate records in electronic laboratory notebooks (ELNs) and ensure compliance with internal quality systems, documentation practices, and training requirements.
• Analyze, interpret, and present assay data using statistical, bioassay, and relative potency analysis tools (e.g., GraphPad Prism, JMP, PLA, SoftMax Pro).
• Present scientific findings, project updates, and technical recommendations to clients, internal stakeholders, and cross-functional teams.
• Provide technical guidance, mentorship, and support to junior scientists and cross-functional team members.
• Collaborate with Quality, Regulatory, Manufacturing, Process Development, Project Management, and Business Development teams to support project objectives and timelines.
• Support new product development, assay platform expansion, technology transfer, and continuous improvement initiatives.
• Investigate technical issues, perform root cause analysis, and implement solutions to improve assay performance and reliability.
• Ensure timely delivery of high-quality results that meet client expectations and regulatory requirements.
• Comply with Environmental Health and Safety (EHS), quality, documentation, training, and company policies.

Requirements

• Ph.D. in Cell Biology, Immunology, Molecular Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field with 5+ years of relevant industry experience; or
• M.S. in a related field with 8+ years of relevant industry experience; or
• B.S. in a related field with 12+ years of relevant industry experience.
• Strong experience in the development, qualification, validation, troubleshooting, and transfer of potency assays for biologics (e.g., antibodies, recombinant proteins, vaccines, cell therapies, gene therapies).
• 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/luminescence-based detection technologies, and automated or semi-automated assay workflows.
• Working knowledge of ICH Q6B, USP, FDA and EMA expectations, GMP/GLP requirements, data integrity principles, and CMC considerations for biologics development.
• Proficiency with scientific and statistical data analysis tools (e.g., GraphPad Prism, JMP, PLA, SoftMax Pro).
• Experience 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 with neutralizing antibody detection assays or client-facing technical discussions.
• Prior mentoring, scientific leadership, project leadership, or project management experience.
• Experience supporting assay transfer into GMP testing environments.
• Strong technical writing skills for authoring protocols, reports, SOPs, and client-facing technical content.
• Ability to translate complex biological and analytical data into clear, scientifically sound conclusions.
• Excellent problem-solving, organizational, communication, collaboration, and presentation skills.
• Ability to manage multiple projects in a fast-paced, deadline-driven environment.
• Commitment to quality, compliance, documentation discipline, data integrity, and continuous improvement.
• Experience using ELNs, controlled document systems, and bioassay analysis platforms in a regulated environment.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Schedule

Full-time, Monday–Friday, 8:00 AM–5:00 PM, with additional hours as needed. Candidates within a commutable distance of Fremont, CA are encouraged to apply.

Pay

$125,000 – $135,000 annually.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.