Scientist I - Quality Control, Data Review
Core
Execute and document cGMP Quality Control testing, review analytical and microbiological data, and operate lab equipment to ensure compliance in biologics manufacturing.
Role type
Quality Control Scientist (Data Review)
Builds
Biologics drug substance and cell line products for clinical manufacturing
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, Good Documentation Practices (GDP), SOP adherence, analytical data review, microbiological data review, basic to moderately complex lab equipment operation, logbook management
Preferred skills
Analytical chemistry knowledge, clean room procedures, aseptic technique, EMPOWER system (HPLC), Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), ELISA, compendial methods testing
Technologies
EMPOWER system, HPLC, SEC, CE, cIEF, RP-HPLC, ELISA
Responsibilities
Review analytical and microbiological data, read and update standard operating procedures (SOPs), perform monthly routine checks of lab logbooks, operate basic and moderately complex equipment, support data entry and lab housekeeping
Seniority
Individual Contributor (IC), Entry to Mid-level