Crescent Biopharma

Director/Senior Director, GMP Quality Assurance Operations

Waltham, MA Full-time On-site
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Job 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.

Frequently Asked Questions

What does the Director/Senior Director, GMP Quality Assurance Operations role at Crescent Biopharma involve?

The Director/Senior Director, GMP Quality Assurance Operations position at Crescent Biopharma in Waltham, MA is a full-time role. 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.

What skills are required for Director/Senior Director, GMP Quality Assurance Operations at Crescent Biopharma?

Key skills for this role include: API.

What is the salary for Director/Senior Director, GMP Quality Assurance Operations at Crescent Biopharma?

The salary for this position is not publicly listed. You can negotiate during the interview process. Check Glassdoor or Levels.fyi for estimates.

Is the Director/Senior Director, GMP Quality Assurance Operations position at Crescent Biopharma remote or on-site?

This position is On-site. The role is based in Waltham, MA.

How do I apply for Director/Senior Director, GMP Quality Assurance Operations at Crescent Biopharma?

You can apply for this position directly through the employer's careers page. Click the 'Apply Now' button on this page to be redirected to the original listing. Make sure your resume is ATS-optimized. Use SpotChange's free ATS test to check.

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About This Role

Director/Senior Director, GMP Quality Assurance Operations at Crescent Biopharma is a full-time qa & testing position in Waltham, MA. Key skills include API. Education: Master's Degree preferred. Experience: 5+ years.

This role is classified as on-site and is suitable for senior-level professionals. Ghost Score 20/100 (Probably Active) indicates this listing is probably active with recent employer engagement.

To apply, visit the official application page through the Apply Now button above. SpotChange Jobs provides AI-powered career tools including resume optimization, ATS testing, interview preparation, and salary negotiation assistance.