Director/Senior Director, Drug Product
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 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. In this role, you will bring extensive subject matter expertise along with a proven track record 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 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
- 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
Nice To Haves
- Prior experience working with ADCs is highly preferred
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
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.
- savings plan (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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
