•Led critical product manufacturing activities with tasks associated from dispensing through assembly and packaging of device products. •Reviewed batch documentation for accuracy and completeness following all operation and followed Master operating procedures (MOP), specifications, manufacturing procedures, and all other GMP documents.•Managed group of six Manufacturing Associates and assisted in training of manufacturing personnel to support production operations.

•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)

•Led a group of 10 Manufacturing Associates and assisted in training of manufacturing personnel to support production operations. •Executed in process and final test release materials for cartridge manufacturing. Performed Quality Control tasks on an automated production line in a clean-room environment•Wrote procedures for quality and system improvements ensuring that highest quality criteria were met. Participated in studies for troubleshooting production processes.•Collected and analyzed Coagulation monitor data to ensure requirements validation for final release. Cross-trained to inspect product prior to shipping. •Performed a variety of quality inspections and tests, to insure proper handling of blood based material.•Worked in close collaboration with engineers and scientists to support R&D activities.

•Performed manual assemble on Sherpa assembly line. •Verified arm assembly serial number in PC barcode.•Operate various equipment within the production environment

•Performed Functional Tests on both new and existing product lines.•Inspected each assembled product.