2025-07-15
University of Pittsburgh
Other
/yr
employee
contract
Pittsburgh
Pennsylvania
15260
United States
QC Assistant Director - IMCPL
The QC Assistant Director 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 Assistant Director will collaborate closely with Process Development, Manufacturing, and QA to support product release, CMC filings, and quality and oversee execution of QC testing strategies for identity, purity, composition, safety, activity/potency, and sterility of autologous and allogeneic CGT products.
Leads team and supports strategic initiatives for senior leadership. Organizes and monitors projects, assesses risks and issues, and prepares presentations and communications. Develops policies and procedures and ensures compliance with regulations. Maintains records, monitors budgets, and performs related financial duties.
The QC Assistant Director 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 Assistant Director will collaborate closely with Process Development, Manufacturing, and QA to support product release, CMC filings, and quality and oversee execution of QC testing strategies for identity, purity, composition, safety, activity/potency, and sterility of autologous and allogeneic CGT products.
Sitting and standing for long periods. Reading same print on computer, tubes, vials, equipment and various things around the lab.
Walking between buildings and around campus. Lifting up to 30 pounds carboy. Bending and stretching to put away lab supplies.
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.
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