Senior Director, ADC Drug Substance Development

Crescent Biopharma; Waltham (MA); On-site; USD 225,000 - 245,000; Full time

Benefits offered by this job

100% employer-paid benefits

Flexible PTO

Equity

Performance bonus

Job summary

Crescent Biopharma is seeking a seasoned CMC leader to oversee process development and manufacturing for our antibody drug conjugate pipeline. You will drive DS development, tech transfer, and oversight of external CDMOs, ensuring GMP compliance and timely program milestones.

In this role you will partner with QA, Regulatory, Clinical, and Supply Chain to align CMC activities with IND/IMPD/BLA submissions and commercialization goals, while mentoring teams across functions.

Qualifications

• 8+ years in ADC bioconjugation process development and external CDMO oversight.
• Hands-on DS manufacturing development and external CDMO management.
• Conjugation chemistries and downstream DS purification methodologies.
• Experience leading cross-functional teams and regulatory interactions.

Responsibilities

• Lead bioconjugation process development, tech transfer, and external manufacturing operations.
• Direct ADC DS efforts and strategy for early phase development and commercialization.
• Provide SME guidance for DS development and manufacturing.
• Coordinate CMC activities with QA, Regulatory, Clinical, and Supply Chain.
• Prepare and review CMC sections for regulatory submissions.

Skills

Communication

Leadership

Program management

Cross-functional collaboration

Education

Ph.D./M.S./B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field

Job description

Crescent Biopharma is seeking a seasoned CMC leader to oversee process development and manufacturing for our antibody drug conjugate pipeline. You will drive DS development, tech transfer, and oversight of external CDMOs, ensuring GMP compliance and timely program milestones.

In this role you will partner with QA, Regulatory, Clinical, and Supply Chain to align CMC activities with IND/IMPD/BLA submissions and commercialization goals, while mentoring teams across functions.