Manufacturing Associate 1
Current1. Proficient in various purification techniques including affinity chromatography, viral inactivation, anion/cation exchange chromatography, ultrafiltration/diafiltration, and bulk fill.2. Utilize MODA for electronic batch record keeping ensuring real-time data collection and compliance with regulatory standards.3. Experience in utilizing ASCTrac for material transactions, ensuring accurate inventory management.4. Skilled in standardizing and utilizing pH/conductivity meters, as well as SoloVPE spectrophotometer for product concentration analysis.5. Experienced in routine and non-routine collection of bioburden, endotoxin, and QC retain samples at each purification stage.6. Proficient in operating various purification equipment including pumps, scales, flowmeters, mixers, filter integrity testers, and depth filters.7. Processed in cleanrooms using aseptic techniques, ensuring product integrity and preventing contamination.8. Conducted shift exchanges in the absence of supervisors and training new personnel, contributing to leadership development and team performance improvement.9. Ensure adherence to company guidelines and compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) to maintain product quality and regulatory standards.