Full Job Description
Are you looking for your next great opportunity in analytical development? Look no further! 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.
Here's what you'll do:
Bioassay Design, Development, Qualification, and Transfer
• 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.
Technical Documentation, Quality, and Compliance
• 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.
Data Analysis and Scientific Communication
• 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.
Cross-Functional Collaboration
• 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.
Product Development, Technology Transfer, and Continuous Improvement
• Support new product development activities, assay platform expansion, technology transfer, and continuous improvement initiatives.
• Contribute to efforts that improve assay robustness, efficiency, and reliability.
Additional Requirements and Success Metrics
• 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.
Qualifications
The ideal candidate:
• 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. Experience with neutralizing antibody (NAb) assays and relative potency analysis is a plus.
• Hands-on experience performing cell-based assays, using fluorescence and luminescence detection systems, and supporting assay development and optimization activities.
• Experience using scientific and statistical data analysis software such as GraphPad Prism, JMP, PLA, SoftMax Pro, or similar applications is preferred.
Additional Information
The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Candidates within a commutable distance of Fremont, CA are encouraged to apply.
Salary range: $100,000 - $110,000/yr.
• 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