Senior Director, Analytical Development
Core
Lead analytical development and quality control strategy for a pharmaceutical pipeline from early development through commercial launch and post-approval lifecycle, focusing on small-molecule oral solid dosage products.
Role type
Senior Director, Analytical Development (Executive/Hands-on IC)
Builds
Small-molecule oral solid dosage products and future modalities
Domain
Pharmaceutical / Analytical Chemistry / Regulatory Affairs
Required skills
Analytical method development, validation, transfer, and lifecycle management, GMP operations, CMC submission authoring, regulatory engagement (FDA), stability strategy, critical quality attributes (CQAs) definition, external laboratory governance, organizational building and scaling
Preferred skills
Animal health regulatory requirements (FDA CVM, VICH guidelines)
Technologies
HPLC, GC, dissolution testing, stability testing equipment, CDMO management platforms
Responsibilities
Define and execute global analytical development and quality control strategy, serve as accountable executive for GMP analytical operations, lead analytical method development and validation, own dissolution strategy, author and review analytical content for NADA CMC technical sections, direct drug substance analytical strategy, establish and oversee stability strategies, lead cross-functional definition of critical quality attributes, establish and oversee commercial QC operations, provide executive oversight of deviations and OOS events, serve as senior analytical subject-matter expert in interactions with FDA CVM, select and manage external analytical laboratories and CDMOs, build and scale a high-performing analytical organization, establish operating models balancing internal capabilities with strategic outsourcing
