Director of Drug Product Development & CDMO Strategy

Medium; Waltham (MA); On-site; USD 250,000 - 285,000; Full time

Benefits offered by this job

Base salary

Performance bonus

Equity

Benefits package

Flexible PTO

Job summary

Crescent Biopharma is seeking an accomplished CMC professional to oversee drug product development, technology transfer, and external manufacturing for biologics and ADCs. The role sits within the Technical Operations Team, delivering CMC strategy and leadership across IND-enabling activities through late-stage validation and commercialization.

The candidate will bring extensive subject-matter expertise, proven program management, and external CDMO oversight skills to ensure GMP, data integrity,

Qualifications

• Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field required.
• At least 12 years of experience in DP development, MSAT, and external CDMO DP manufacturing.
• Hands-on DP development, external CDMO management, and person-in-plant exposure.
• Deep knowledge of liquid, lyophilized, and high-concentration DP development.
• Experience managing external CDMO teams from early to late-phase development and verification.

Responsibilities

• Lead DP development, technology transfer, and manufacturing operations for biologics and ADCs.
• Strategize early phase development, tech transfer, process characterization, validation, and commercial launch.
• Provide SME guidance across DP formats and oversee CDMO GMP DP manufacturing and MSAT.
• Monitor timelines and act as primary DP contact for internal teams and external partners.
• Coordinate CMC activities with QA, Regulatory, and Clinical teams to align development and regulatory goals.

Education

PhD/MS/BSc in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field

DP development

MSAT

CDMO management

External manufacturing

Job description

Crescent Biopharma is seeking an accomplished CMC professional to oversee drug product development, technology transfer, and external manufacturing for biologics and ADCs. The role sits within the Technical Operations Team, delivering CMC strategy and leadership across IND-enabling activities through late-stage validation and commercialization.

The candidate will bring extensive subject-matter expertise, proven program management, and external CDMO oversight skills to ensure GMP, data integrity,