Senior Scientist, Analytical Development

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