Michel Silva Email & Phone Number

West Chester, Pennsylvania, United States

• Wrote of relevant SOP’s or manufacturing batch records to support new processes.• Prepared validation protocols, deviation reports, change controls in accordance with cGMP’s.• Promoted manufacturing self-assessment audit for manufacturing readiness. • Developed and implemented kanban system for process improvement.• Worked with highly integrated and fast-paced interdisciplinary team on process scale up activities, process troubleshooting, and cGMP manufacture of clinical drug substance. • Executed process operation according to SOPs such as media/buffer preparation, filling equipment set-up using aseptic technique.• Played key role in troubleshooting process disturbances, identifying resolution, and implementing corrective and preventive measure.• Performed inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.

Cherry Hill, New Jersey, United States

• Provided necessary leadership to achieve product quality, cost control, cGMP compliance, safety, and the execution of the production schedule to support the customer service requirements. • Monitor and evaluate all functions and efforts related to filing, inspection, and packaging.• Coordinates and oversees daily activities of hourly production employees.• Initiates and completes investigative reports for production related process deviations. • Provides phase-in training for new and existing employees. • Provides conflict resolution and handles general problems/requests when necessary. • Evaluates/enforces current practices within areas of responsibility. • Coordinates orders for production related materials.

Buena, New Jersey, United States

• Performed filling production activities in a GMP environment.• Performed compounding activities and filtration processes.• Revised cGMP documentation.• Assisted in pilot plant operation. • Documented production activities according to cGMP regulations.• Trained coworkers and lead teams for production process.• Performed manufacturing review of batch record.• Assisted in production related activities (autoclaving, changeover, CIP, etc.)• Collected batch sample according to product specifications.

Cherry Hill, New Jersey, United States

• Oversees the work of other employees, gives direction, and prioritizes work assignment.• Sets up and operates automated filling and support equipment such as fillers, stoppering units, and capper.• Performed preventive maintenance tasks on filling equipment, such as inspection and cleaning of machine parts.• Performed trouble-shoots, repairs, and adjust filling equipment, as necessary. • Completed applicable paperwork and logbook entries in accordance with approved procedure. • Performed all job duties using acceptable aseptic techniques.• Performed cleanup of equipment and room, including walls and floor.• Collected samples and performed fill weight check.• Worked with aseptic technique in a class 100 clean room environment.

Bachelor'S Degree, Management Information Systems, General

Associate'S Degree, Business Administration And Management, General, 3.6

Activities and Societies: Phi Theta Kappa

Bachelor'S Degree, Business Administration And Management, General