Scientist I Analytical Development

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.

Heres what youll 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. 

• 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.

Remote Work :

No

Employment Type :

Full-time