Bioassay Scientist
Core
Subject matter expert performing method establishment and validation of Drug Substances and Drug Products using ELISA and ECL methodologies under cGMP guidelines.
Role type
Bioassay Scientist (cGMP)
Builds
Validated analytical methods for biotech drug substances and products
Domain
Pharmaceutical testing / Biotech / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ELISA methodology, electrochemiluminescence (ECL), cGMP compliance, data analysis, LIMS proficiency, experimental design, regulatory adherence (FDA/DEA/EPA)
Preferred skills
CRO/CDMO experience, method establishment, cGMP validations
Technologies
Molecular Devices Softmax Pro, LIMS
Responsibilities
Design and perform complex experiments per SOPs, validate methods, analyze data, train and mentor junior staff, ensure on-time delivery for clients
Seniority
Mid-level, hands-on IC
