- Salary
- $200k – $260k
- Location
- Waltham, MA
- Workplace
- Onsite
- Type
- Full-time
- Department
- Openings
- Seniority
- Senior
- Source
- 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 either as single agents or 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.
Skills
GMPFDARisk ManagementComplianceChange Management
Benefits
Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environmentCompetitive compensation, including base salary, performance bonus, and equity100% employer-paid benefits packageFlexible PTO; also, two, one-week company-wide shutdowns each yearA commitment to your professional development, with access to resources, mentorship, and growth opportunities
