Job Description

We are seeking a highly skilled and motivated individual to join our team in a critical role supporting the development, optimization, and validation of analytical methods:

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.
• Execution of complex GMP release and stability assays including cell-based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
• Author and review SOPs and technical reports.
• Acting as an SME resource to external partners
• 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

• Bachelor’s degree with 3-6 years of experience
• Master’s degree with 1-3 years of experience
• 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 is preferred
• Knowledge of ICH/USP guidelines.
• Proven track record of functional and potency assay qualification and validation.
• 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’ site 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 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.