Scientist I, Analytical Development and Clinical QC
Core
Lead analytical method validation, verification, transfer, and lifecycle management for late-stage clinical and commercial biologics.
Role type
Senior IC analytical scientist (biologics)
Builds
Robust, phase-appropriate analytical methods for monoclonal antibodies, bispecifics, and fusion proteins
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical method validation, method transfer, OOS/OOT investigation, assay troubleshooting, regulatory submissions, GxP compliance, chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays, impurity testing (HCP, DNA, Protein A)
Preferred skills
Quality by Design (QbD), Design of Experiments (DOE), statistical data analysis, CDMO oversight, regulatory guidance knowledge (ICH Q5E, Q6B, Q8-Q12), digital lab systems (LIMS, ELN, CDS), AI-enabled tools
Technologies
SEC, RP, IEX, CE-SDS, cIEF, UV/Vis, fluorescence, CD, JMP, Empower, SoftMax
Responsibilities
Lead analytical method validation, transfer, and compendial method verification; Develop strategies for method lifecycle management; Lead cross-functional teams in assay troubleshooting and OOS/OOT investigations; Design investigation plans and execute laboratory experiments; Review analytical test procedures and performance metrics; Author and review validation protocols and reports for regulatory submissions; Provide subject matter expertise for regulatory agency interactions.
Seniority
Mid-level, hands-on IC