Group Lead – Sample Testing & Method Transfer (GMP)

Eurofins-posted 6 months ago
Full-time • Mid Level
Cambridge, MA
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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.

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