Christopher Somma Email & Phone Number

Swiftwater

Oversee and direct all safe and compliant Flu manufacturing processes from Inoculation through Sterile Filtration in a cGMP, FDA regulated facility: - Consistently meets or exceeds all manager performance expectations. Regularly takes on additional roles/tasks outside job description.- Coach and develop production personnel from Technician through Lead.

Merck Sharp And Dohme - West Point

• Frontline supervisory role involving direct oversight of all aspects of a dynamic Alum-based recombinant in-line Formulation and Filling vaccine operation in a cGMP regulated facility.
• Effectively partnered with and developed collaborative cross-functional relationships with Operations support staff (Engineering, Validation, Quality, Safety, and Deviation Management) in order to drive quality and.
• Successfully developed and implemented corrective actions in response to process deviations, in order to ensure accurate transfer of sterile product inputs. Designed Formulation trouble-shooting photo library job aid.
• Overhauled and redesigned departmental fire-evacuation maps to ensure a safe and compliant working environment. Identified and drove departmental cold vault door safety project to allow employees to safely enter and.
• Effectively conducted ongoing management of 12 direct reports including payroll, annual training, one-on-one coaching and safety/compliance adherence. Drove numerous off-shift training requirements including annual.

Merck Sharp And Dohme - West Point

• Effectively performed various production and laboratory activities related to manufacturing and testing of Pneumovax 23®, Hepatitis A, Varicella, Measles, Mumps, and Rubella vaccines including cell expansion and.
• Tested safety of Measles, Mumps, Rubella, Varicella and Hepatitis-A vaccines using various tissue cultures cell lines.
• Screened for contaminants present in tissue culture fluids evidenced by cytopathic effects.
• Screened for presence of noncytopathogenic viral agents via hemadsorption method.Varicella Potency Testing
• Determined potency and identity of production/MRL procured Varicella vaccine samples.
• Determined Varicella vaccine efficacy through virus serial dilutions and inoculation into MRC-5 tissue cultures cell line, incubation and maintenance of test cell cultures, stain cell cultures and plaque count potency.

Merck Sharp And Dohme - West Point

Performed production activities related to manufacturing of Hepatitis A vaccine including media prep, cell expansion, purification, inactivation and alum processing.

Merck Sharp And Dohme - West Point

• Successfully executed scale-up fermentation of live infectious Meningitidis and Haemophilius Influenza Bacteria. Purified microbial fermentation broths and extracted intermediates in PedVax and PneumoVac vaccines..
• Performed alcohol fractionation, ultracentrifugation and diafiltration of fermentation products.
• Separated, isolated and purified intermediate product solutions by batch or continuous, medium centrifugation. Purified product batch using multiphase extractions and resin absorption methods.
• Chemically bonded purified polysaccharides and conjugated them to N. Meningitidis protein to produce final vaccine.

Marietta, PA

Successfully participated in an FDA audited validation and start-up of the Wyeth-Ayerst Influenza Vaccine Production Facility (IVPF). Effectively authored and executed all aspects of the Scientific Climate Systems Egg Chiller Validation Project. Successfully authored and implemented IQ/OQ/PQ protocols for controlled temperature rooms, refrigerators and.

Mba, Project Management

Bachelor Of Science (Bs), Microbiology, General