Analyst II, Analytical Development - Biologics - Eurofins CDMO Alphora, Inc.
Core
Develop, validate, and transfer analytical methods for characterizing biologics (mAbs, ADCs, fusion proteins) to support drug development and regulatory filings.
Role type
Senior IC analytical development scientist
Builds
Analytical methods and data for biologics characterization
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
HPLC, LC-MS, CE, Empower 3, bioassay development, method validation, GMP/GDP compliance, experimental design, technical writing
Preferred skills
Cell-based assay development, bioassay qualification, regulatory filing strategy
Technologies
Empower 3, HPLC, LC-MS, CE
Responsibilities
Lead analytical method transfers, development, and validation; plan and execute laboratory studies; develop and optimize separation methods and bioassays; write and review SOPs; mentor junior team members; collaborate with cross-functional teams.
Seniority
Mid-level, hands-on IC