Senior Director, Head of Analytical Development
Core
Lead analytical development for small molecule and oligonucleotide drug portfolios from pre-IND through NDA/MAA approval, setting scientific direction and building the team.
Role type
Senior Director, hands-on IC with people leadership
Builds
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> Analytical methods, specifications, and control strategies for drug substance and product
Domain
Biopharmaceuticals, small molecule and oligonucleotide therapeutics
Required skills
Analytical method development and validation, control strategy design, regulatory CMC content authoring, CDMO/CRO management, team building and coaching, ICH/GMP/USP guidelines knowledge, small molecule analytics, nucleic acid therapeutic analytics
Preferred skills
ASO/siRNA analytics, CNS or rare disease development experience
Technologies
HPLC, LC-MS, NMR, stability testing systems, LIMS
Responsibilities
Define analytical strategy for drug substance and product; lead method development, qualification, validation, and transfer; author and review analytical CMC content for regulatory submissions; oversee CDMOs and CROs for testing and stability; hire and develop the analytical team; partner with cross-functional teams to support program decisions
Seniority
Senior Director, hands-on IC with people leadership