Senior Scientist, Analytical Research and Development (Onsite)
Core
Senior Scientist leading analytical method validation, release, and stability testing for biologics drug substances and products in a GMP environment.
Role type
Senior Scientist, Biologics Analytical R&D
Builds
Release and stability testing data for clinical and commercial biologics
Domain
Biopharmaceuticals / Biologics / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ELISA methods, cell-based potency assays, mammalian cell culture, residual ELISA, GMP compliance, analytical method validation, change control, deviation management, chromatographic techniques, NMR analysis, process analytical technology (PAT), assay development, bioanalytical analysis, biochemical assays, cell-based assays, innovative thinking
Preferred skills
LIMS, SoftMax Pro, electronic notebook, cGxP guidelines (USP/EP/ICH/FDA), analytical life cycle management, regulatory submissions, qPCR, compendial methods
Technologies
SoftMax Pro, LIMS, NMR, qPCR
Responsibilities
Execute GMP release and stability testing for biologics; Validate and implement analytical methods; Support critical reagent qualifications; Act as subject matter expert across analytical platforms; Support biologics registrations and troubleshooting; Manage project timelines and deliverables; Support compliance audits and investigations.
Seniority
Senior, hands-on IC
