GMP Analytical Testing Lead – Cell & Gene Therapy

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, apply with us today!  

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 client’s 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.

• Bachelor’s degree in a scientific discipline with 3–8 years of experience, or Master’s degree with 2–5 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.

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 www.eurofinsus.com.

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