Principal Scientist, Analytical Development, Oligo and Small Molecule
Core
Lead analytical development for oligonucleotide and small molecule drug substances and products, translating strategies from development to manufacturing across CMOs and partners.
Role type
Principal Scientist, Analytical Development
Builds
Robust, scalable, and compliant analytical control strategies for innovative CNS therapies
Domain
Biopharmaceuticals / Oligonucleotide and Small Molecule Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, qualification, validation, transfer, and GMP testing; Technical troubleshooting; Data interpretation; Method lifecycle management; Design of analytical control strategies and stability programs; Cross-functional leadership
Preferred skills
Experience with virtual networks of CMOs and external partners; Expertise in phase-appropriate analytical strategies across multiple modalities
Technologies
HPLC, LC-MS, CE, NMR, DSC, TGA, FTIR, UV-Vis, ICP-MS, XRF, DLS, Zeta potential, Particle size analysis, Raman spectroscopy, Mass spectrometry, NMR spectroscopy, DSC, TGA, FTIR, UV-Vis, ICP-MS, XRF, DLS, Zeta potential, Particle size analysis, Raman spectroscopy
Responsibilities
Serve as Analytical Lead across CMC programs; Lead analytical method development, qualification, validation, transfer, and GMP testing activities; Drive technical troubleshooting, data interpretation, and method lifecycle management; Design and implement phase-appropriate analytical control strategies, specifications, and stability programs
Seniority
Principal, hands-on IC with strategic oversight
