Crescent Biopharma

Associate Director, Quality Control

Waltham, MA · Director

Sponsorship not specified$160k-$200kDetected 23 hours ago

GMPProtein AnalysisLeadershipCommunicationCollaborationMentoringMicrosoft Office

About the role

For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
You will report directly to the head of QC and will serve as key contributor in overseeing day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories (CTLs).
Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products
Ensure CDMOs/CTLs perform release, stability and in-process testing in accordance with GMP requirements, Crescent standards, and regulatory expectations.
Generate COAs for intermediate material, Drug Substance/Drug Product and collaborate with QA to facilitate batch disposition
Trend and evaluate stability data according to ICH in support of shelf life/expiry date assignment and extensions
Schedule, chair and facilitate stability review board meetings in support of stability data evaluation and assignment of product shelf-life
Schedule, chair and facilitate stability review board in support of stability data evaluation and assignment of product shelf-life
Schedule, chair and facilitate specification review board in support of new product specification and revisions
Collaborate with partners, CDMOs/CTLs to transfer, methods for release and stability testing as needed according to phase appropriate approach
Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA).
Participate in internal and external cross-functional meetings as QC representative and manage program timelines

Review and approve specific sections of vendor batch records and other required documentation
Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E).
This role is based in Waltham, MA and you must have experience in biotech.

Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.

Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients.
Education & Experience
Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities.

We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected.

This listing is sourced directly from Crescent Biopharma's careers page and normalized into a canonical job model.