GMP Analytical Testing Lead – Cell & Gene Therapy

We are seeking a highly qualified professional with extensive experience in GMP-regulated analytical method development validation and technology transfer. This individual will play a critical role in supporting our clients GMP-compliant sample testing and analytical operations while also serving as a Group Leader overseeing a team of Eurofins PSS employees embedded at the client site.

Primary Responsibilities:

• Perform complex GMP release and stability testing including cell-based functional assays such as PCR ELISA and NGS.
• Lead the technical transfer qualification and validation of bioassays for lot release and characterization of cell and gene therapy products and associated critical materials.
• Author and review GMP documentation including standard operating procedures (SOPs) technical protocols and validation reports.
• Collaborate with cross-functional teams to support method development process and product characterization comparability studies and laboratory investigations.
• Analyze trend and interpret assay data to ensure consistent performance and compliance with regulatory expectations.
• Ensure all activities are conducted in strict accordance with GMP guidelines and quality standards.

Leadership Responsibilities:

• Supervise and support a team of Eurofins PSS employees ensuring high performance and adherence to GMP standards.
• Participate in interviewing onboarding and training of new team members.
• Promote a culture of quality compliance and continuous improvement.
• Manage team scheduling workload distribution and performance evaluations.
• Serve as a liaison between the client and Eurofins PSS to ensure alignment on project goals and expectations.

Qualifications :

• Bachelors degree in a scientific discipline with 38 years of experience or Masters degree with 25 years in a GMP-regulated laboratory setting.
• Proven expertise in the validation of analytical methods in strict compliance with Good Manufacturing Practices (GMP).
• Demonstrated success in the transfer of analytical methods into GMP-compliant laboratories ensuring readiness for lot release and stability testing.
• Extensive hands-on experience with GMP sample testing including execution of release and stability assays.
• Strong working knowledge of regulatory expectations (e.g. FDA EMA) related to method lifecycle management including qualification validation and ongoing monitoring.
• Effective team collaborator with excellent oral and written communication skills to support cross-functional GMP operations.
• Self-motivated and detail-oriented with strong problem-solving skills in a regulated laboratory environment.
• Supervisory or team leadership experience in a GMP lab is highly desirable.
• Familiarity with potency assays (e.g. cell-based assays ELISA) is a plus.
• Experience with Laboratory Information Management Systems (LIMS) is advantageous.

Additional Information :

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader
• 60 Minute Meeting Onsite to Meet the Team

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