Bhavesh Sheth Email & Phone Number

Mountain View, CA

• 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.

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.
• 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.

Fremont, CA

• 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.

San Jose, CA

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

Campbell, CA

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

Diploma

Electronics Tech Technician