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 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.