CMC Consultant
Core
Define and execute CMC strategy and operations to advance a lead asset through the NDA pathway, guiding drug product development and ensuring regulatory readiness for a device-enabled at-home acne treatment.
Role type
Senior CMC Consultant (Fractional/Advisory)
Builds
Drug product development, analytical strategies, and regulatory documentation for a combination product (corticosteroid + intradermal device)
Domain
Biotechnology / Pharmaceutical Manufacturing / Dermatology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy, formulation development, analytical method development/validation, stability program management, GMP manufacturing oversight, regulatory document preparation, vendor management (CDMOs/CROs)
Preferred skills
Combination product experience, FDA interaction history, late-stage development support
Technologies
None explicitly listed
Responsibilities
Define CMC development strategy, support outsourced drug substance and product development with CDMOs, establish critical quality attributes and specifications, guide analytical method validation, manage external vendor relationships, prepare regulatory documents for IND/NDA submissions, support FDA interactions
Seniority
Senior, hands-on IC with strategic advisory capacity