Director of Downstream Process Development CMC

6 hours ago

Boston, Massachusetts, United States EPM Scientific Full time

Director, Downstream Process Development

Location:
Greater Boston Area

Position Summary:

Currently partnered with a leading clinical-stage biotech that is developing several first-in-class traditional biologics across multiple stage development. They are looking to bring on an experienced Director of Downstream Process Development to spearhead their late-stage biologics process development activities for several assets. This role will oversee purification process design, optimization, characterization, and validation to support clinical and commercial manufacturing. The ideal candidate brings deep technical expertise, leadership experience, and a proven track record in large pharma or top-tier biotech environments.

Key Responsibilities:

  • Lead downstream process development for multiple biologics, including chromatography, filtration, and viral clearance steps.
  • Drive process characterization (PC) and process validation (PV) strategies for late-stage programs, ensuring compliance with global regulatory requirements.
  • Develop and implement robust control strategies and risk assessments for commercial readiness.
  • Collaborate cross-functionally with upstream development, analytical sciences, MSAT, and Quality to ensure seamless tech transfer to GMP manufacturing.
  • Author and review CMC sections for regulatory filings (IND, BLA, MAA).
  • Manage and mentor a team of scientists and engineers, fostering technical excellence and career growth.
  • Stay current with industry trends, regulatory guidance, and emerging technologies in downstream processing.

Qualifications:

  • Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
  • 10+ years of experience in biologics process development, with at least 5 years in leadership roles.
  • Expertise in downstream purification for CHO-expressed biologics.
  • Strong experience in late-stage development, PC/PV, and commercial process readiness.
  • Proven track record in large pharma or leading biotech organizations.
  • Excellent understanding of regulatory expectations (FDA, EMA) and quality systems.
  • Strong leadership, communication, and project management skills.

Preferred Experience:

  • Hands-on experience with scale-up and tech transfer to GMP facilities.
  • Familiarity with QbD principles and statistical tools (DoE, risk analysis).
  • Experience supporting global regulatory submissions.

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