Director, ADC Drug Substance

Crescent Biopharma•Waltham, MA

1d•$225,000 - $245,000

About The Position

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. We are seeking an accomplished CMC professional to oversee process development, and manufacturing for our antibody drug conjugate pipeline. Within the Technical Operations Team, you will help build CMC strategy and deliver technical leadership across all stages of drug substance development from IND-enabling activities through late-stage process validation and commercialization. In this role, you will bring 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
8+ years of experience in ADC bioconjugation process development, and external CDMO manufacturing oversight
Demonstrated track record in DS manufacturing development, including hands-on technical skill, external CDMO management, and person-in-plant exposure
Extensive knowledge of conjugation chemistries and downstream DS purification methodologies
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 DS with DP, AS, QC, supply chain, and QA
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 bioconjugation process development, technology transfer, and external manufacturing operations
Direct ADC DS efforts and contribute to strategy for early phase development, tech transfer, process characterization, validation, and commercial launch
Provide technical, subject matter expert guidance for all aspects of ADC DS development and manufacturing
Oversee external CDMO GMP DS manufacturing operations functioning as the primary point of contact
Monitor development, MSAT, and manufacturing timelines ensuring alignment with program objectives
Serve as a key CMC DS contact for both internal teams and external partners
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, Clinical, and Supply Chain 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

Benefits

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.
medical, dental, vision, life insurance, short- and long-term disability.
401(k).
long-term incentive program.
Vacation – Unlimited PTO
Sick time – 10 days per calendar year
Holiday pay, including two Company shut downs
Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child
FMLA
Military Leave