Principal Scientist, CMC Analytical
Core
Subject matter expert in analytical development for oral solid dosage products, ensuring robust control of product quality from early development through commercialization.
Role type
Principal Scientist, CMC Analytical
Builds
Oral solid dosage veterinary drugs targeting aging drivers
Domain
Veterinary medicine / Small-molecule pharmaceuticals
Required skills
Analytical method development and validation, Data trending and interpretation, Regulatory authoring, Root cause analysis, Technical strategy setting, CDMO management
Preferred skills
Sponsor-side pharma experience, Animal health/veterinary experience, Managing tech transfer programs
Technologies
HPLC, UPLC, Dissolution testing, KF, GC
Responsibilities
Lead analytical development and quality control strategy for programs; Partner with CDMO partners as primary technical point of contact; Lead drug substance (API) analytical method development, qualification, and validation; Perform in-depth review and interpretation of analytical data across release and stability programs; Identify subtle trends in complex data sets and translate findings into risk assessments; Serve as technical lead during OOS, OOT, and atypical result investigations; Own preparation and technical accuracy of analytical data packages for regulatory submissions; Mentor junior scientists and analysts.
Seniority
Principal, hands-on IC with strategic oversight
