Senior Manager, QC Technical Operations

Role: Quality Control lead supporting startup and operational functions at ElevateBio's Pittsburgh facility, focusing on preparing the site for clinical and commercial manufacturing of cell and gene therapies for US and EU markets. Responsibilities: execute site startup projects, develop and revise QC procedures, support technical transfer with MSAT, establish laboratory systems compliant with GMP, oversee training programs, review data, manage deviations and investigations, participate in audits, and mentor staff. Transition to ongoing QC oversight including documentation, investigations, and logistics. Requirements: Bachelor's degree with 8+ years (or advanced degree with proportionate experience) in GMP manufacturing, with extensive GMP and QC knowledge; leadership experience; expertise in clean room qualification (ISO 14644), compendial and rapid safety testing, gene/cell therapy assays (qPCR, ddPCR, flow cytometry, ELISA); proficiency with electronic systems (LIMS, QMS, ERP). Preferred: experience in cell and gene therapy manufacturing. High-Value: GMP, cell/gene therapy, laboratory investigations, regulatory inspections, site startup. Work Setup: on-site in Pittsburgh, with physical capabilities for laboratory work including lifting and PPE use; flexibility to work nights, weekends, and holidays.