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Crescent Biopharma

Posted 1 month ago

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Director, ADC Drug Substance

Waltham, MAOn-siteFull-time

AI Summary

Director, ADC Drug Substance leads bioconjugation process development and manufacturing for an oncology pipeline, providing technical leadership and CDMO oversight from IND-enabling through commercialization.

About this role

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. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
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.

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

Education & Experience

  • 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

What We Offer

  • 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.

    • Salary Range

    The salary range for this position is $225,000 to $245,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
    Additional Description for Pay Transparency:
    The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

    Skills

    ADCBioconjugationCDMOGMPICHManufacturingProcess DevelopmentQuality AssuranceRegulatory SubmissionsTechnology Transfer

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