Drug Product Development Leader (DP, MSAT & CDMO)

Socket.dev; Waltham (MA); On-site; USD 260,000 - 285,000; Full time

Benefits offered by this job

Competitive compensation

Equity

100% employer-paid benefits package

Flexible PTO

Two, one-week company-wide shutdowns

Job summary

Crescent Biopharma is seeking an accomplished CMC professional to oversee drug product development, technology transfer, and external manufacturing for a pipeline of biologics and ADCs. The role provides technical leadership across IND-enabling activities through late-stage process validation and commercialization.

In this position you will lead DP development, support tech transfer, and coordinate strategies with QA, Regulatory, and Clinical teams to meet program goals.

Qualifications

• Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
• At least 12 years of experience in DP development, MSAT, and external CDMO DP manufacturing
• Demonstrated track record in DP manufacturing development, including hands-on technical skill, external CDMO management, and person-in-plant exposure
• Deep knowledge of liquid, lyophilized, and high-concentration drug product development
• 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 DP with DS, AS, QC, supply chain, and QA
• Prior experience working with ADCs is highly preferred
• 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

Responsibilities

• Lead DP development, technology transfer, and manufacturing operations for biologics and ADCs
• Direct DP efforts and contribute to strategy for early phase development, tech transfer, process characterization, validation, and commercial launch
• Provide technical subject matter guidance across liquid, lyophilized, and high-concentration DP formats
• Oversee CDMO GMP DP manufacturing and MSAT operations functioning as the primary point of contact
• Monitor development and manufacturing timelines ensuring alignment with program objectives
• Serve as a key DP subject matter expert contact for both internal teams and external partners
• Contribute to formulation development efforts working with CMC and Analytical Sciences teams
• 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, 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
• Embrace a collaborative, diverse, and inclusive team environment

Education

Ph.D./M.S./B.S. in Biochemistry/related field

Job description

Crescent Biopharma is seeking an accomplished CMC professional to oversee drug product development, technology transfer, and external manufacturing for a pipeline of biologics and ADCs. The role provides technical leadership across IND-enabling activities through late-stage process validation and commercialization.

In this position you will lead DP development, support tech transfer, and coordinate strategies with QA, Regulatory, and Clinical teams to meet program goals.