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Crescent Biopharma · 1 day ago

Director / Senior Director, CMC Drug Product

Waltham, MA

Full-time

Onsite

Director/Executive

$223K/yr - $288K/yr

8+ years exp

Crescent Biopharma is focused on building a leading oncology company with innovative therapies for cancer patients. The role involves overseeing formulation development, drug product development, and manufacturing for biologics and ADCs, while providing technical leadership and ensuring alignment with regulatory goals.

BiotechnologyHealth CareMedical Device

Responsibilities

Lead formulation, DP development, and manufacturing strategy for biologics and ADCs

Direct DP efforts from early phase development through process characterization, validation and commercial launch

Provide technical guidance across liquid, lyophilized, and high-concentration DP formats

Oversee CDMO DP manufacturing operations and function as the primary point of contact

Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives

Serve as a key subject matter expert contact for both internal teams and external partners

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

Champion a collaborative, diverse, and inclusive team environment

Qualification

Formulation developmentDrug product developmentCDMO oversightGMP complianceBiologics experienceADCs experienceRegulatory submissionsLeadership skillsCommunication skillsProblem-solving