Drug CMC Lead
Core
Lead Chemistry, Manufacturing & Controls (CMC) strategy and operations for a clinical-stage drug-device combination product, driving advancement through the NDA regulatory pathway.
Role type
Senior IC CMC Lead (Drug-Device Combination)
Builds
Drug substance and drug product for at-home inflammatory acne treatment
Domain
Biotechnology / Pharmaceutical Manufacturing / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy, formulation development, analytical method validation, GMP manufacturing, regulatory submissions, CDMO management, technology transfer, quality systems, cross-functional leadership
Preferred skills
Combination product (drug + device) experience, FDA inspection history, scaling from clinical to commercial
Technologies
cGMP, FDA regulations, analytical instrumentation
Responsibilities
Oversee drug substance and product development at CDMOs; define quality attributes and acceptance criteria; manage analytical method development and validation; lead comparability strategies; select and manage CDMO partners; drive technology transfer and scale-up; engage with FDA on CMC submissions; mentor junior engineers
Seniority
Senior, hands-on IC with leadership responsibilities
