Senior Director, Analytical Development
Core
Strategic leadership for analytical development and quality control across the veterinary pharmaceutical pipeline, ensuring FDA CVM compliance and method lifecycle management.
Role type
Senior Director, Analytical Development (Hands-on IC with executive oversight)
Builds
FDA-approved veterinary drugs targeting longevity in dogs
Domain
Veterinary medicine / Pharmaceutical development / Regulatory affairs
Required skills
Analytical chemistry, GMP operations, FDA CVM regulatory strategy, method development and validation, stability program design, CMC section authoring, external lab governance, organizational leadership, budget management
Preferred skills
Animal health regulatory knowledge (VICH), small-molecule oral solid dosage expertise
Technologies
HPLC, GC, dissolution testing, stability chambers, LIMS
Responsibilities
Set global analytical development and QC strategy; Ensure GMP compliance and inspection readiness; Lead method development, validation, and transfer for small-molecule oral solids; Author analytical content for NADA CMC submissions; Manage stability strategies and shelf-life assignment; Oversee external GMP testing laboratories and CDMOs; Lead cross-functional CQA identification and lifecycle management; Provide executive oversight of deviations, OOS/OOT events, and CAPAs; Mentor and scale the analytical organization.
Seniority
Senior Director, strategic leadership with hands-on technical execution
