Principal Scientist, Analytical Development
Core
Leading analytical development strategies for small molecule drug substances and products across the product lifecycle, including method development, validation, transfer, and GMP testing.
Role type
Principal Scientist, Analytical Development (hands-on IC with leadership)
Builds
GMP analytical methods, control strategies, and stability programs for small molecule CNS therapies
Domain
Biopharmaceuticals / Small molecule drug development
Required skills
Analytical chemistry, small molecule development, GMP compliance, impurity characterization, method validation, CRO/CMO management, regulatory submissions, stability programs
Preferred skills
PhD in Analytical Chemistry, experience with solid oral dosage forms, agile environment adaptability
Technologies
HPLC, GC, LC-MS, NMR, DSC, TGA, dissolution testing, stability chambers
Responsibilities
Lead analytical method development, qualification, validation, and transfer; Develop phase-appropriate analytical control strategies; Provide hands-on technical leadership for troubleshooting and investigations; Manage external CRO/CMO partners; Review and approve analytical documentation; Support regulatory submissions and commercialization readiness
Seniority
Principal, hands-on IC with strategic oversight
