Associate Director, CMC, Analytical Development
Core
Develop analytical methodology and characterization for new drug substance and product to support preclinical, clinical, and commercial manufacturing.
Role type
Associate Director, CMC, Analytical Development
Builds
Analytical methods, specifications, and reference standards for small molecules and solid oral dosage forms.
Domain
Biopharmaceuticals / Neuroscience / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and validation, HPLC/GC/dissolution methods, impurity and degradation product identification, reference standard qualification, CDMO management, regulatory CMC knowledge, GMP/GLP compliance, project management, technical troubleshooting
Preferred skills
Experience with Phase 3 clinical trials, regulatory filing preparation (IND/NDA/MAA), managing FTEs at GMP testing CROs
Technologies
HPLC, GC, dissolution, compendial methods
Responsibilities
Design and execute analytical strategies including method development, qualification, and validation; Manage analytical activities across internal teams and CDMOs; Resolve technical issues and review deviation events; Author analytical sections for regulatory submissions; Collaborate with Quality Control and Assurance for GMP release
Seniority
Senior, hands-on IC with management responsibilities
