Associate Director, Quality Control in Waltham, Massachusetts at Crescent Biopharma

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.

• Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products
• Serve as QC point of contact for CDMOs/CTLs ensuring appropriate quality control oversight of manufacturing campaigns
• 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
• Monitor CDMO/CTL stability studies, review of raw data and approval of stability summary reports
• 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
• Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control
• Review and approve specific sections of vendor batch records and other required documentation
• Collaborate with partners, CDMOs/CTLs to transfer, methods for release and stability testing as needed according to phase appropriate approach
• Participate in the qualification, validation, and lifecycle management of analytical methods.
• Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA).
• Ensure strong data integrity practices and compliance with GMP, ICH, and global regulatory guidelines.
• Assist in the establishment of QC systems, SOPs, and processes suitable for a lean and scalable operation.
• Participate in internal and external cross-functional meetings as QC representative and manage program timelines
• Provide leadership, mentoring, and technical development within the QC function.

• B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 10 years of industry experience in biologics analytical development and QC.
• Deep expertise in method qualification, validation, and lifecycle management.
• Significant experience overseeing QC activities at CDMOs/CTLs.
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E).
• Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities.
• Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.
• Hands on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP.
• Demonstrated ability to lead QC operations in a small or virtual biotech environment.
• Strong communication, leadership, and crossfunctional collaboration skills.

• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer-paid benefits package
• Flexible PTO; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities