Senior Scientist I - Quality Control - Data Review
Core
Execute and document cGMP Quality Control testing, review analytical and microbiology data, and ensure compliance with SOPs and GMP/GDP in a biologics manufacturing facility.
Role type
Senior Scientist I, Quality Control Data Review
Builds
Biologics drug substance and clinical manufacturing products
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, GMP/GDP adherence, analytical data review, microbiology data review, SOP development and maintenance, laboratory operations, technical documentation
Preferred skills
EMPOWER software proficiency, HPLC (High-Performance Liquid Chromatography), Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), Reverse Phase HPLC, ELISA, plate-based assays, compendial methods knowledge
Technologies
EMPOWER, HPLC, SEC, CE, cIEF, RP-HPLC, ELISA
Responsibilities
Review and update Standard Operating Procedures (SOPs), perform monthly routine checks of lab logbooks, review analytical and microbiology data, assist with training of junior staff, coordinate day-to-day tasks in supervisor's absence
Seniority
Senior, hands-on IC
