Laboratory Scientist Phys-Chem QC 80-100%
Core
Execute routine physico-chemical testing for biologics, large molecules, and small molecules in a QC environment under cGMP.
Role type
Laboratory Scientist (Phys-Chem QC)
Builds
Analytical data and reports for drug product quality control
Domain
Pharmaceutical/Biotech Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
U/HPLC (SEC, IEX, RP, surfactant), CE-SDS, icIEF, protein content analysis, compendial methods (pH, color, clarity, subvisible particles), cGMP compliance, SOP adherence, GDocP documentation, mobile phase preparation, equipment calibration and troubleshooting, 6s standard maintenance, analytical method validation support, laboratory equipment maintenance and requalification
Preferred skills
Laboratory information management systems (LIMS), Empower software, Electronic Laboratory Journal, English (written and spoken)
Responsibilities
Independently execute routine physico-chemical testing, review and approve basic laboratory operational tasks, assist in investigation and troubleshooting of laboratory equipment issues, maintain 6s standard for chemical inventory and consumables management, lead organization and on-time maintenance/requalification of assigned laboratory equipment, support analytical method validation or transfers, contribute to laboratory operational optimization and process improvement initiatives
Seniority
Mid-level, hands-on IC