Senior Scientist, Analytical Development and Quality Control - Early Phase
Core
Lead analytical and QC activities for IND-enabling and early phase clinical studies, developing test methods and characterizing drug substance and product attributes.
Role type
Senior Scientist, Analytical Development and Quality Control
Builds
Analytical test methods, stability data, and regulatory documentation for targeted protein degradation medicines
Domain
Biopharmaceuticals, Targeted Protein Degradation, Early Phase Clinical Development
Required skills
HPLC method development, stability study design, method validation, CDMO/CRO oversight, risk mitigation, OOS/OOE/OOT investigation, statistical trending, cGMP compliance
Preferred skills
Gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, FTIR
Technologies
HPLC, GC, NMR, MS, ICP-MS, FTIR
Responsibilities
Characterize drug substance and product attributes; develop analytical methods for drug substances, products, and stability; manage method validation and QC testing at internal and external partners; execute forced degradation and stability studies; contribute to OOS/OOE/OOT investigations; trend stability data to establish retest periods; review protocols, reports, and specifications.
Seniority
Senior, hands-on IC
