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Gmp Analytical Testing Lead – Cell & Gene Therapy

3-8 years
Not Disclosed
10 June 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary:

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is seeking a GMP Analytical Testing Lead – Cell & Gene Therapy for its client site in Cambridge, MA. This full-time, on-site role offers a unique leadership opportunity in analytical method development, validation, and GMP-compliant bioassay operations for cutting-edge cell and gene therapy products. Perfect for experienced professionals passionate about scientific excellence and regulatory compliance.


Key Responsibilities:

Technical Responsibilities:

  • Execute complex GMP release and stability testing, including PCR, ELISA, and NGS assays.

  • Lead technical transfer, qualification, and validation of bioassays for cell and gene therapy products.

  • Author and review GMP documentation (SOPs, protocols, validation reports).

  • Collaborate with cross-functional teams on method development and characterization studies.

  • Analyze and interpret assay data to ensure regulatory compliance.

  • Uphold strict adherence to cGMP guidelines and internal quality standards.

Leadership Responsibilities:

  • Supervise and mentor a team of Eurofins PSS scientists.

  • Conduct interviews, onboarding, and training for new hires.

  • Promote continuous improvement and GMP best practices.

  • Oversee team scheduling, workload allocation, and performance reviews.

  • Act as a liaison between Eurofins PSS and the client to align on project deliverables.


Required Skills & Qualifications:

  • Bachelor’s degree in a scientific field (3–8 years of GMP lab experience) or Master’s degree (2–5 years).

  • Proven expertise in analytical method validation and transfer in GMP environments.

  • Hands-on experience with GMP release and stability assays.

  • Knowledge of regulatory standards (FDA, EMA) for method lifecycle management.

  • Strong problem-solving and cross-functional collaboration skills.

  • Excellent communication (oral and written) abilities.

  • Supervisory or leadership experience in a GMP lab setting preferred.

  • Familiarity with potency assays (cell-based, ELISA) is a plus.

  • Experience with LIMS systems is desirable.


Perks & Benefits:

  • Comprehensive medical, dental, and vision plans.

  • Life and disability insurance coverage.

  • 401(k) retirement plan with company match.

  • Paid vacation and holidays.

  • Career advancement in a global life sciences leader.


Company Description:

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) provides specialized laboratory staffing solutions to leading pharmaceutical and biotechnology companies. With over 55 years of scientific expertise, Eurofins ensures regulatory-compliant, high-quality laboratory services tailored to the evolving needs of the life sciences industry.


Work Mode:

On-Site – Cambridge, MA, USA


Call-to-Action:

Ready to lead GMP analytical testing for advanced cell and gene therapy products? Apply today and advance your scientific career with Eurofins, a trusted name in pharmaceutical testing and quality assurance.