Senior Director, ADC Drug Substance Development & CMC

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

Benefits offered by this job

Competitive compensation with base, +%

100% employer-paid benefits

Flexible PTO

Two company-wide shutdowns

Professional development opportunities

Job summary

Crescent Biopharma is seeking a seasoned CMC professional to oversee process development and manufacturing for its antibody–drug conjugate pipeline. In the Technical Operations Team you will shape CMC strategy and provide technical leadership across IND-enabling to late-stage validation and commercialization.

The role requires extensive expertise, strong program management, and hands-on DS development with external CDMO oversight to ensure GMP, quality, and regulatory readiness throughout

Qualifications

• Ph.D., M.S., or B.S. in a related field.
• 8+ years of ADC bioconjugation process development and external CDMO oversight.
• Hands-on DS manufacturing development with external CDMO management.
• Conjugation chemistries and downstream DS purification expertise.
• Experience managing external CDMO teams from early to late phase development to validation.
• Strong GMP, ICH, and regulatory knowledge for biologics and ADCs.

Responsibilities

• Lead bioconjugation process development, tech transfer, and external manufacturing operations.
• Direct ADC DS efforts and strategy for early phase development, tech transfer, process characterization, validation, and commercial launch.
• Provide SME guidance for DS development and manufacturing.
• Oversee external CDMO GMP DS manufacturing as primary contact.
• Coordinate CMC activities with QA, Regulatory, Clinical, and Supply Chain.

Skills

Leadership

Project management

Communication

Education

Ph.D./M.S./B.S. in Biochemistry/ Chemistry/ Bioengineering/ Biotechnology/ Chemical Engineering

Job description

Crescent Biopharma is seeking a seasoned CMC professional to oversee process development and manufacturing for its antibody–drug conjugate pipeline. In the Technical Operations Team you will shape CMC strategy and provide technical leadership across IND-enabling to late-stage validation and commercialization.

The role requires extensive expertise, strong program management, and hands-on DS development with external CDMO oversight to ensure GMP, quality, and regulatory readiness throughout