Scientist I, BioChemical Analysis
Core
Perform method evaluation, optimization, transfer, and validation activities for Large Molecules/Biologics product development and stability studies under cGMP guidance.
Role type
Scientist I, BioChemical Analysis
Builds
Analytical methods and stability data for biologics
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC, electrophoresis, spectroscopy, compendial assays, cGMP compliance, method development, method transfer, validation, technical documentation drafting, peer review
Preferred skills
None stated
Technologies
HPLC, UPLC, CE, spectroscopy
Responsibilities
Perform method evaluation, optimization, transfer, and validation activities; Execute analytical testing for biologics; Draft and review technical documents including methods, validation protocols, and reports; Perform ad hoc sample testing and support method lifecycle activities; Follow standard operating procedures with strong attention to detail; Ensure accurate, legible, and compliant documentation in accordance with cGMP requirements; Perform peer review of laboratory notebooks, logbooks, and technical documentation; Train and coach peers on methods, instrumentation, and laboratory practices
Seniority
Individual Contributor, 4+ years experience (Master's) or 6+ years (Bachelor's)
