QC Manager , Cell and Gene Therapy

Title: OC Manager, Cell and Gene Therapy Location: Onsite, Pittsburgh, PA 15219 Type: Direct-Hire/Permanent Hours: Standard business hours Start: ASAP Overview: Join a cutting-edge cell and gene therapy (CGT) team as a QC Manager leading quality control for early-phase clinical programs. This role offers the opportunity to apply your expertise in flow cytometry, immunology, and gene-editing technologies (CRISPR/Cas9) while overseeing QC operations—from assay development and qualification to product release and stability testing. You’ll collaborate closely with Process Development, Manufacturing, and QA to drive innovation and ensure GMP compliance in a rapidly growing field. If you are interested in learning more please apply ! Responsibilities Oversee execution of QC testing strategies for identity, purity, composition, safety, activity/potency, and sterility of autologous and allogeneic CGT products. Design, qualify, and implement analytical assays for preclinical and early-phase product development, including flow cytometry, cytotoxicity, qPCR, ELISA, and sterility assays. Lead method transfer and validation in alignment with ICH and FDA guidelines. Review and approve Master Production Control Records, batch records, and stability protocols. Develop and implement QC strategies for Short-Term and Long-Term Stability Studies (STSS/LTSS) in compliance with IND requirements. Lead deviation investigations, Out of Specification (OOS) assessments, and CAPA generation with QA oversight. Manage and maintain critical QC equipment, including CliniMACS Prodigy, Sepax, G-Rex, closed-system cell culture bags, and NC-200. Support technology transfer and scale-up of analytic methods across internal and partner organizations Requirements Bachelor's degree in immunology, virology, cell biology, molecular biology, or a related discipline. Proven expertise in immunologic assays, flow cytometry standardization, gene-editing delivery systems (viral and non-viral), endotoxin, mycoplasma, activity and potency assay development. Demonstrated ability to lead QC activities in GMP or IND-enabling environments. Strong understanding of assay development lifecycle, including qualification and validation parameters. Preferred Qualifications: Familiarity with regulatory guidance related to CGT product testing and submission is a plus Prior experience drafting SOPs, risk assessments, and deviation reports in a GMP or GLP environment. Experience with QC data analysis, integrity review, and generation of Certificate of Analysis (CoA). Strong communication, leadership, and documentation skills. #LI-MD1 #M3 Ref: #558-Scientific