Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (all genders) (full-time, permanent)
Core
Lead and mentor scientists in separation-based assays (HPLC, capillary electrophoresis) to support biologics mAb and DS process development, characterization, validation, and GMP manufacturing investigations.
Role type
Principal Research Scientist I/II (Biologics Quality Control)
Builds
Analytical test methods and validation for early-stage biologics clinical programs
Domain
Biopharmaceuticals / Biologics Analytical R&D
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, capillary electrophoresis, mass spectrometry, ELISA, protein and impurity analysis, method development and validation, technical writing, project management, cross-functional collaboration
Preferred skills
Head of Quality Control (HQC) experience, automation of high-throughput methods
Technologies
HPLC, capillary electrophoresis, mass spectrometry, ELISA
Responsibilities
Lead and mentor scientists specializing in separation-based assays; Serve as analytical representative in CMC teams; Act as subject matter expert for analytical test methods; Evaluate and select effective analytical technologies; Prepare and review technical documents for regulatory impact; Collaborate with R&D and PDS&T teams on program transition
Seniority
Principal, hands-on IC with leadership responsibilities