Director/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial)
Core
Lead late-stage process development, validation, and commercial manufacturing of small molecule drug products for clinical trials and global distribution.
Role type
Director/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial)
Builds
cGMP drug products for late-stage clinical trials and commercial launch
Domain
Biopharmaceuticals / Neuroscience / Small molecule manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Late-stage process development and scale-up, Process validation (PPQ), CDMO/CMO management and selection, Regulatory filing support (IND/NDA/MAA), FMEA analysis, Critical Process Parameters (CPP) establishment, Budget management, Team leadership
Preferred skills
Formulation development for solid oral and parenteral dosage forms, Experience with capsule/tablet/spray drying/granulation/blending/bottling/blistering, Ex-US collaboration experience
Technologies
cGMP regulations, FMEA, CPPs
Responsibilities
Lead teams in late-stage process development, scale-up, and validation; Oversee manufacturing processes ensuring quality and regulatory compliance; Manage commercial manufacturing and packaging with supply chain and quality groups; Select and manage CDMOs for late-stage and commercial use; Author and review CMC documents for regulatory submissions; Plan and manage manufacturing budgets; Recruit and develop direct reports
Seniority
Senior Director, hands-on IC with management responsibilities