Job Description

We are seeking a highly skilled and motivated individual with in-depth knowledge of cell-based and potency assays and comfortable with troubleshooting. The Scientist will serve as SME for mRNA and gRNA potency assays to support several client programs.

Primary Responsibilities:

• Optimize, technical transfer, qualification, and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
• Acting as an SME resource for potency assays.
• Execution of complex GMP release and stability assays such as cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
• Author and review SOPs and technical reports.
• Work with cross-functional groups within the client environment to participate in various aspects of method development, transfer, process and product characterization, comparability, and investigations.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.

Qualifications

The Ideal Candidate will Have:

• Strong background in cell culture and experience working with cell lines and primary human cells.
• Experience with functional, or potency assay transfer and execution in a GMP laboratory.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, flow cytometry, ELISA, and NGS.
• Experience using data analysis software including JMP
• Knowledge of ICH/USP guidelines.

Minimum Qualifications:

• Bachelor’s degree with 3-8 years of experience
• Master’s degree with 2-5 years of experience
• PhD degree with 0-1 years of experience
• Must have experience with potency assay execution
• Team player with excellent oral and written communication skills
• Independently motivated, detail-oriented, and excellent problem-solving abilities.

Additional Information

The position is full-time, Monday-Friday from 8am-5pm. Candidates living within a commutable distance of Cambridge, MA and the surrounding areas 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 Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.