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Director, CMC Biologics

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Proclinical

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Location:
United States , San Francisco

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

225000.00 - 260000.00 USD / Year
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Job Description:

Proclinical is seeking a Director, CMC Biologics to lead and execute Chemistry, Manufacturing, and Controls (CMC) strategies for protein therapeutic programs. This role focuses on advancing programs from late preclinical stages through all phases of clinical development. The successful candidate will oversee external partnerships, ensure regulatory compliance, and collaborate cross-functionally to achieve clinical milestones efficiently. Additionally, you will manage a team of consultants and build an internal team to support biologics CMC activities. This is a high-impact position requiring technical expertise in biologics development, manufacturing, and regulatory processes, with the ability to thrive in a fast-paced biotech environment.

Job Responsibility:

  • Develop and implement integrated CMC strategies aligned with clinical development plans and timelines
  • Lead CMC activities from late preclinical stages through regulatory filings for all clinical phases
  • Define and execute phase-appropriate control strategies and proactively address CMC risks
  • Oversee formulation, process, and analytical development, including upstream/downstream processes and drug product formulations
  • Manage CDMO selection and oversight for biologic development, manufacturing, and tech transfer
  • Ensure cGMP compliance, adherence to timelines, budgets, and quality standards
  • Author and review CMC sections for regulatory filings and support agency interactions
  • Collaborate cross-functionally with Quality, Regulatory, Clinical, Nonclinical Development, Commercial, and Finance teams to align CMC strategies with program goals
  • Develop and manage CMC budgets and integrate timelines into overall program plans

Requirements:

  • Advanced degree (PhD, MS, or BS) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field
  • Strong experience in biologics CMC development, including late-stage clinical development and regulatory filings
  • Expertise in protein therapeutic development, manufacturing, and managing CDMOs in a virtual biotech model
  • In-depth knowledge of FDA and ICH CMC requirements for biologics
  • Proven track record in planning and executing biologics CMC development, GMP manufacturing, and regulatory submissions
  • Experience with monoclonal antibodies and fusion proteins
  • Strategic thinker with strong project management, organizational, and communication skills
  • Ability to operate effectively in a lean, fast-paced environment with a high level of accountability

Additional Information:

Job Posted:
February 19, 2026

Employment Type:
Fulltime
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