Scientist I - Analytical Development

Eurofins USA Discovery Services•Fremont, CA

5d•Onsite

About The Position

Drive the development and advancement of innovative cell-based bioassays that support biologics characterization, potency determination, stability studies, and product development programs. The Scientist I with Eurofins DiscoverX Products, LLC plays a key role in designing, optimizing, qualifying, and executing analytical methods while generating high-quality scientific data to inform critical development decisions. This position combines hands-on laboratory expertise with data analysis, cross-functional collaboration, and a commitment to quality, regulatory compliance, and data integrity to accelerate the delivery of safe and effective biologic products.

Requirements

M.S. degree in a related scientific field with 2+ years of relevant industry experience; or B.S. degree in a related scientific field with 3+ years of relevant industry experience.
Deep knowledge of cell and molecular biology techniques, including sterile technique, and assay troubleshooting and optimization.
Hands-on experience with mammalian cell culture, cell-based bioassays, reporter gene assays, mechanism-of-action assays, ELISA, flow cytometry, cell banking workflows, and bioassay data analysis.
Hands-on experience performing cell-based assays, using fluorescence and luminescence detection systems, and supporting assay development and optimization activities.

Nice To Haves

Experience with neutralizing antibody (NAb) assays and relative potency analysis is a plus.
Experience using scientific and statistical data analysis software such as GraphPad Prism, JMP, PLA, SoftMax Pro, or similar applications is preferred.

Responsibilities

Support the development, optimization, qualification, and execution of cell-based bioassays for potency testing, product characterization, stability studies, and comparability assessments.
Perform routine and non-routine laboratory experiments using established procedures and scientific methodologies.
Support the development, characterization, and maintenance of assay-ready cell lines and cell banks for internal programs and client projects.
Assist in evaluating assay performance characteristics, including accuracy, precision, specificity, sensitivity, linearity, robustness, and reproducibility.
Maintain laboratory reagents, consumables, and inventory to support daily operations.
Execute qualification studies, analyze data, and maintain accurate documentation in compliance with quality and data integrity requirements.
Maintain accurate records in electronic laboratory notebooks (ELNs) and ensure compliance with quality systems, documentation practices, training requirements, and data integrity standards.
Prepare and maintain protocols, reports, SOPs, assay records, qualification documentation, and other technical documents.
Adhere to established laboratory procedures, safety guidelines, and quality requirements to ensure accurate and reliable results.
Analyze and interpret assay data using appropriate scientific and statistical tools.
Summarize experimental results and communicate findings to project teams and management.
Utilize scientific and statistical data analysis software such as GraphPad Prism, JMP, PLA, SoftMax Pro, or similar platforms.
Collaborate with Quality, Regulatory, Manufacturing, Process Development, and Project Management teams to support project objectives and timelines.
Participate in team meetings and provide technical updates on assigned projects.
Work effectively within cross-functional teams to achieve departmental goals.
Support new product development activities, assay platform expansion, technology transfer, and continuous improvement initiatives.
Contribute to efforts that improve assay robustness, efficiency, and reliability.
Ensure timely delivery of high-quality results that meet internal quality standards and project requirements.
Comply with Environmental Health and Safety (EHS), quality, documentation, training, confidentiality, and company policies; perform other duties as assigned.