2025-06-26
University of Pittsburgh
Other
/yr
employee
contract
Pittsburgh
Pennsylvania
15260
United States
IMPCL QC Manager
The QC Manager will lead the Quality Control function for cell and gene therapy (CGT) products supporting preclinical and early-phase clinical development. The ideal candidate will possess deep expertise in immunology, gene-editing technologies (e.g., CRISPR/Cas9), CGT manufacturing platforms, and assay development. This role is responsible for overseeing QC operations including sampling, in-process testing, release testing, stability studies, assay qualification, and analytic method transfer while ensuring regulatory and GMP compliance. The QC Manager will collaborate closely with Process Development, Manufacturing, and QA to support product release, CMC filings, and quality investigations.
Directs daily laboratory operations of a division, department, function, or program. Conducts and manages quality assurance and quality control and instructs staff on quality control and analytical procedures. Develops complex design projects and laboratory procedures and evaluates new products. Writes grant applications and manuscripts independently. Ensures compliance with all applicable regulations.
The QC Manager will lead the Quality Control function for cell and gene therapy (CGT) products supporting preclinical and early-phase clinical development. The ideal candidate will possess deep expertise in immunology, gene-editing technologies (e.g., CRISPR/Cas9), CGT manufacturing platforms, and assay development. This role is responsible for overseeing QC operations including sampling, in-process testing, release testing, stability studies, assay qualification, and analytic method transfer while ensuring regulatory and GMP compliance. The QC Manager will collaborate closely with Process Development, Manufacturing, and QA to support product release, CMC filings, and quality investigations.
Sitting and standing for long periods.
Bending and lifting up to 30 pounds.
Walking and traveling between buildings and the Oakland campus.
Reading small print on paper, tubes and vials.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
PI274323763
