Director/Senior Director, Drug Product

About the role

Crescent Biopharma is seeking an accomplished CMC professional to oversee drug product development, technology transfer, and external manufacturing for our pipeline of biologics and antibody drug conjugates. Within the Technical Operations Team, you will help build CMC strategy and deliver technical leadership across all stages of drug product development from IND-enabling activities through late-stage process validation and commercialization.

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

Requirements

• 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

Benefits

• 100% employer-paid benefits package (medical, dental, vision, life insurance, short- and long-term disability)
• Company savings plan (401(k))
• Long-term incentive program
• Flexible PTO and 10 days sick time per calendar year
• Two, one-week company-wide shutdowns each year
• 16 weeks parental leave within one year of the birth/adoption/foster care of a child
• Holiday pay, including FMLA and Military Leave
• Professional development with access to resources, mentorship, and growth opportunities

Pay

The salary range for this position is $250,000 to $285,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, and geography.