Director / Senior Director, CMC Drug Product
Apply for the Director / Senior Director, CMC Drug Product role at Crescent Biopharma .
About Us
Crescent Biopharma is building a world‑leading oncology company focused on next‑wave therapies for cancer patients. Our pipeline includes a PD‑1 x VEGF bispecific antibody and novel antibody‑drug conjugates (ADCs), aimed at rapidly advancing transformative therapies for a range of solid tumors. For more information, visit crescentbiopharma.com.
Position Overview
We seek an accomplished CMC professional to oversee formulation development, drug product (DP) development, and manufacturing for biologics and ADCs. This role will build CMC strategy, provide technical leadership across all stages of DP development, from IND‑enabling activities through late‑stage process validation and commercialization, with a history of program management and external CDMO oversight.
Responsibilities
- 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 serve as the primary point of contact.
- Monitor development, MSAT, and manufacturing timelines to ensure alignment with program objectives.
- Serve as a key subject‑matter expert contact for 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.
Education & Experience
- 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.
- 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 excelpaced environments and manage multiple priorities.
What We Offer
- Opportunity to join a mission‑driven team where you will 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.
- Commitment to professional development with access to resources, mentorship, and growth opportunities.
Salary and Benefits
The anticipated salary range for this position 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 relevant experience, education, and geography.
This position is eligible to participate in the Company’s long‑term incentive program, 401(k) plan, medical, dental, vision, and other employee benefit programs. Unlimited PTO, 10 days sick time, two company shutdowns, 16 weeks parental leave, FMLA, and military leave are available.
Equal Opportunity
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. 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.
We may use artificial intelligence tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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