Senior Scientist, Analytical Development

Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2024, Eurofins generated total revenues of EUR 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.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 TransferDesign, 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 ComplianceAuthor, 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 CommunicationAnalyze, 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 CollaborationProvide 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 ImprovementSupport 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 MetricsEnsure 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; orM.S. degree in a related scientific field with minimum 8+ years of relevant industry experience; orB.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 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 - $135,000Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Biotechnology