Scientist I/II: Bioassay
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
Scientist I/II (Bioassay)
Builds
Validated analytical methods for biotech drug substances and products
Domain
Pharmaceutical testing / Bioassay
Required skills
cGMP compliance, ELISA methodology, ECL platforms, data analysis, LIMS proficiency, SOP adherence, regulatory knowledge (FDA, DEA, EPA)
Preferred skills
Method establishment experience, cGMP validation experience, mentoring junior staff
Technologies
Molecular Devices Softmax Pro, LIMS, ECL platforms
Responsibilities
Design and perform complex experiments per regulatory requirements, validate methods, analyze data and communicate results, train and mentor junior staff, utilize LIMS and laboratory equipment
Seniority
Junior to Mid-level, hands-on IC
