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.
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