Associate Scientist
Medimmune Llc (Astrazeneca Biologics)
Santa Clara ,Ca
•Performed key activities in manufacturing products from cell banks through aseptic filling and packaging of drug products. Executed various tasks associated with production of clinical trial materials such as Pandemic flu vaccines, Respiratory Syncytical virus (RSV) vaccines and Epstein Barr virus (EBV).•Played an active role in manufacturing FluMist® Commercial with operations included Master Virus Seed (MVS) production, and Clinical Trial Material for Annual Safety trials.•Conducted in-depth trainings of less experience personnel on GMP, GLP, and ISO Guidelines, BSL2 and BSL2+• Participated in Process Optimization, Scale-up and Validation Studies for Biomanufacturing of Phase I-III Products, including Vaccines, Cell Therapeutics and Proteins.•Experienced in Mammalian Cell Culture, Cell Transfection and Microbial Fermentation.•Batch and Fed-Batch Stirred Tank Bioreactor Operation and Troubleshooting.•Membrane Filtrations (Ultrafiltration, Diafiltration and Tangential Flow Filtration)•Proficiency in most Documentation Systems (Lab Notebooks, SOPs, BPRs, Process Validation, Quality Control, Technical Reports, Technology Transfer, Expense Budgets, Work Orders and Purchasing Systems)•Played intensive role in bringing two manufacturing facilities into GMP compliance, Involved with the facility start-ups from commissioning through equipment validation and manufacture of Consistency lots. •Conducted EMP sampling and monitoring of critical process equipment and environment. •Evaluated equipment status, solutions, materials and processes by reviewing the pertinent records and Monitored processes to identify opportunities for continuous improvement.•Coordinated with Quality Control and Quality Assurance for deviations, change control, batch production records reviews and campaign change.•Completed the Safety Ready Training such as Blood Borne Pathogens, Hazcom, Lab Safety, General Safety and IIPP (Illness and Injury Prevention Program)
