Director / Senior Director, CMC Drug Product

Crescent Biopharma , Inc. • Waltham, MA

1d • $223,000 - $288,000

About The Position

We are seeking an accomplished CMC professional to oversee formulation development, drug product (DP) development, and manufacturing for our pipeline of biologics and ADCs. Within the Technical Operations Team, this role 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. The ideal candidate offers extensive subject matter expertise and has a history of effective program management and external CDMO oversight.

Requirements

• Ph.D., M.S., or B.S. in Biochemistry, Chemistry, Bioengineering, Biotechnology, Chemical Engineering, or related field
• At least 8 years' experience in formulation development, DP development, and external CDMO manufacturing
• Demonstrated leadership in manufacturing development, including hands-on experience and person-in-plant exposure
• Expertise in developing liquid, lyophilized, and high-concentration drug product formulations
• Comprehensive understanding of 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

Nice To Haves

• Experience working with ADCs is highly preferred

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

Benefits

• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
• Competitive compensation, including base salary, performance bonus, and equity.
• 100% employer-paid benefits package.
• Flexible PTO.
• Two, one-week company-wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree