Director/Senior Director, GMP Quality Assurance Operations
crescent-biopharma
| Company | crescent-biopharma |
| Category | Operations & Admin |
| Location | Waltham |
| Remote | On-site (inferred) |
| Employment | Full-time |
| Level | Director |
| Salary | Not stated by the employer |
| Posted | 28 Jul 2026 |
| Last verified | 9 Aug 2026 |
| Source | Employer ATS (lever) |
Description
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing strategic and hands-on GMP Quality leadership for manufacturing activities supporting the lead biologics program and future pipeline growth. Partnering closely with the GMP Quality and cross-functional Technical Operations teams, you will ensure reliable clinical supply while building the Quality infrastructure needed to successfully advance programs into late-stage development and commercialization.
You will provide Quality oversight across master cell bank, working cell bank, drug substance, drug product, and finished goods within a global outsourced manufacturing network. You will bring deep biologics experience spanning clinical through late-stage development, with demonstrated expertise supporting clinical supply, technology transfer, CDMO selection and management, process validation/PPQ, and commercial readiness, including BLA support.