Group Lead – Sample Testing & Method Transfer (GMP)

Eurofins • Cambridge, MA

244d

About The Position

We are seeking an experienced professional with a strong background in analytical method development and technology transfer within a GMP-regulated environment. This role primarily supports our client by performing routine GMP sample testing, method validation, and bioassay execution. In addition to technical responsibilities, this individual will serve as a group leader, overseeing a team of Eurofins PSS employees embedded within the client’s operation.

Requirements

• Bachelor’s degree in a scientific discipline with 3–8 years of relevant experience, or a Master’s degree with 2–5 years of experience.
• Proven experience in analytical method validation in alignment with GMP regulations.
• Demonstrated success in the transfer of analytical methods into GMP-regulated laboratories.
• Hands-on experience performing routine sample testing in a GMP environment.
• Strong knowledge of regulatory expectations related to method lifecycle management (e.g., FDA, EMA).
• Excellent written and verbal communication skills; able to work collaboratively within cross-functional teams.
• Self-motivated, highly organized, and detail-oriented with strong problem-solving capabilities.
• Previous laboratory supervision or leadership experience is preferred.
• Experience with potency assays (e.g., cell-based assays, ELISA) is a plus.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsibilities

• Perform complex GMP release and stability assays, including cell-based functional assays such as PCR, ELISA, and NGS.
• Support method transfer, qualification, and validation of bioassays for lot release and characterization of cell and gene therapy products and critical materials.
• Author and review SOPs, technical reports, and other documentation in compliance with regulatory standards.
• Collaborate with cross-functional teams on method development, product/process characterization, comparability studies, and technical investigations.
• Analyze, trend, and interpret data to assess and maintain consistent assay performance and method robustness.
• Supervise and support the daily performance of the Eurofins PSS team.
• Assist in the recruitment and onboarding of new team members.
• Communicate administrative updates and reinforce company vision and values.
• Ensure high standards of quality, efficiency, and GMP compliance in all laboratory operations.
• Manage shift coverage, scheduling, and resource allocation.
• Support employee growth through performance discussions and development planning.
• Maintain a balanced role between hands-on technical work and leadership duties.
• Cultivate a positive team culture, encouraging collaboration, accountability, and continuous improvement.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree