Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT
$165,000–$200,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead late-phase drug substance process development for a fusion protein program, driving activities from pivotal supply through process validation and characterization. Manage day-to-day technical relationships with CDMO partners, overseeing upstream and downstream workstreams, timelines, and deliverables while ensuring cross-functional alignment on process interfaces and release testing strategies. Define control strategies using QbD principles and statistical modeling to establish proven acceptable ranges and design spaces. Author and review critical documents including study reports, TTPs, and CMC sections for regulatory filings, while collaborating with upstream and downstream SMEs to shape the integrated CMC strategy. Contribute to early-phase process development and vendor evaluations to advance molecules from candidate selection to IND.
Required Qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field
- 5+ years of upstream biologics industry experience
- M.S. degree with 8+ years of experience
- Deep upstream SME expertise in mAb and/or fusion protein process development
- Cell culture process design
- CPP/CQA characterization
- Control strategy
- Tech transfer
- Hands-on bioreactor experience across scales (ambr, 2L/10L, pilot, manufacturing)
- Demonstrated scale-down model development and qualification
- Proven late-phase track record (Phase II/III through PPQ)
- Process characterization studies
- Process validation protocols
- Commercial-readiness documentation
- Proficiency in statistical modeling for process development
- DoE
- Multivariate analysis
- Process capability
- Statistical software (JMP or equivalent)
- Working knowledge of downstream unit operations (chromatography, filtration, viral clearance)
- Experience authoring CMC regulatory sections (IND, IMPD, BLA)
- Demonstrated CDMO management
- Technical oversight
- Deliverable governance
- Manufacturing partner relationship management
Desired Qualifications
- Direct experience with Fc-fusion proteins or other complex biologics modalities
- Background in a startup or clinical-stage biotech
- Breadth and independent judgment
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