Director​/Senior Director, CMC Drug Product

About Us

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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.

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We are seeking an accomplished CMC professional to oversee formulation development, drug product (DP) development, and manufacturing for our pipeline of biologics and ADCs. Within the Technical Operations Team, this role will help build CMC strategy and deliver technical leadership across all stages of drug product development, from IND‑enabling activities through late‑stage process validation and commercialization. The ideal candidate offers extensive subject‑matter expertise and has a history of effective program management and external CDMO oversight.

• Lead formulation, DP development, and manufacturing strategy for biologics and ADCs
• Direct DP efforts from early phase development through process characterization, validation and commercial launch
• Provide technical guidance across liquid, lyophilized, and high‑concentration DP formats
• Oversee CDMO DP manufacturing operations and function as the primary point of contact
• Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives
• Serve as a key subject matter expert contact for both internal teams and external partners
• Prepare and review CMC sections for regulatory submissions (IND/IMPD/BLA)
• Coordinate CMC activities with Quality, Regulatory, and Clinical functions to ensure alignment with development and regulatory goals
• Promote continuous improvement and uphold GMP, data integrity, and compliance standards
• Support budgeting, vendor selection, and contract management of CDMO partners
• Champion a collaborative, diverse, and inclusive team environment

• Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
• At least 8 years’ experience in formulation development, DP development, and external CDMO manufacturing
• Demonstrated leadership in manufacturing development, including hands‑on experience and person‑in‑plant exposure
• Expertise in developing liquid, lyophilized, and high‑concentration drug product formulations
• Experience working with ADCs is highly preferred
• Comprehensive understanding of GMP, ICH guidelines, and regulatory requirements for biologics and ADCs
• A track record of innovation, problem‑solving, and ability to deliver high‑quality work supporting Company objectives
• Outstanding communication and leadership skills, capable of influencing across organizational levels
• Ability to excel in fast‑paced environments and manage multiple priorities

• 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.
• Two, one‑week company‑wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

The anticipated base pay range for this position is:

The anticipated salary range for candidates for this role at the Director level is $223,000 – $246,000 and at the Senior Director level is $260,000-$288,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term…