EPM Scientific · 1 week ago
Director of Downstream Process Development CMC
Boston, MA, US
Full-time
Onsite
Director/Executive
10+ years expEPM Scientific is partnering with a leading clinical-stage biotech focused on developing first-in-class traditional biologics. They are seeking an experienced Director of Downstream Process Development to lead purification process design and optimization for late-stage biologics, ensuring compliance with regulatory requirements and overseeing a team of scientists and engineers.
BiotechnologyRecruiting
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
Qualification
Required
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
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
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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