Director, ADC Drug Substance
About this 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 an accomplished CMC professional to oversee process development, and manufacturing for our antibody drug conjugate pipeline. Within the Technical Operations Team, you will help build CMC strategy and deliver technical leadership across all stages of drug substance development from IND-enabling activities through late-stage process validation and commercialization. In this role, you will bring, extensive subject matter expertise and has a history of effective program management and external CDMO oversight.
\nResponsibilities- Lead bioconjugation process development, technology transfer, and external manufacturing operations
- Direct ADC DS efforts and contribute to strategy for early phase development, tech transfer, process characterization, validation, and commercial launch
- Provide technical, subject matter expert guidance for all aspects of ADC DS development and manufacturing
- Oversee external CDMO GMP DS manufacturing operations functioning as the primary point of contact
- Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives
- Serve as a key CMC DS contact for both internal teams and external partners
- Partner with Quality Assurance to investigate manufacturing deviations
- Prepare and review CMC sections for regulatory submissions (IND/IMPD/BLA)
- Coordinate CMC activities with Quality, Regulatory, Clinical, and Supply Chain 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
- Embrace a collaborative, diverse, and inclusive team environment
- Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
- 8+ years of experience in ADC bioconjugation process development, and external CDMO manufacturing oversight
- Demonstrated track record in DS manufacturing development, including hands-on technical skill, external CDMO management, and person-in-plant exposure
- Extensive knowledge of conjugation chemistries and downstream DS purification methodologies
- Expertise in managing external CDMO teams from early phase development through late phase process characterization and validation
- Thorough understanding of the interdependencies at the interface of DS with DP, AS, QC, supply chain, and QA
- Comprehensive familiarity with 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.
Please note:
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.
Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
#LI-CBIO
Company at a glance
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. Crescent’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.
Top Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) savings plan
- Performance bonus
- Equity
- Unlimited PTO
- Parental leave
- Company-wide shutdowns
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?