Group Lead – Sample Testing & Method Transfer (GMP)

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 clients operation.

Primary 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.

Leadership Responsibilities:

• 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.

Qualifications :

• Bachelors degree in a scientific discipline with 38 years of relevant experience or a Masters degree with 25 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

Additional Information :

The position is full-time and permanent Monday-Friday 8 am-5 pm with overtime as needed. Candidates living near or in Cambridge MA are encouraged to apply.

Excellent full-time benefits include:

• 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 clients quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories please explore our website .

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time