Director of CMC, External Operations
Core
Strategic leadership for outsourced CMC development, managing external manufacturing partners in China to ensure timely, high-quality delivery of GMP clinical supplies and regulatory-compliant activities supporting clinical proof of concept.
Role type
Director of CMC, External Operations
Builds
GMP clinical supplies and regulatory-compliant CMC development activities for clinical-stage programs
Domain
Biopharmaceuticals / Clinical Development / CMC Outsourcing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy development, external partner selection and management, GMP compliance, regulatory submission support, risk management, technical oversight of manufacturing processes, cross-functional collaboration
Preferred skills
Biologics development expertise, negotiation, Mandarin fluency
Technologies
GMP manufacturing systems, regulatory filing platforms
Responsibilities
Develop and execute CMC strategies aligned with clinical timelines; Identify, evaluate, and manage CMO/CDMO partners; Lead negotiation of Manufacturing Service Agreements; Establish governance models with external partners; Provide technical oversight of process development, analytical development, formulation, and technology transfer; Partner with Quality Assurance and Regulatory Affairs for compliance; Provide CMC input into regulatory submissions (IND/CTA/IMPD); Oversee preparation of Module 3 documentation; Collaborate with cross-functional teams to support program advancement.
Seniority
Director, strategic leadership & hands-on management