Lead Bioprocess Associate
Gaithersburg, Maryland, Us
• Lead team as acting co-supervisor for four direct reports.• Trained and responsible for knowing: Making media for mammalian cell culture, monitoring perfusion media filters for clogs, cell passage in Wave Reactors, inoculating 200 L stirred tank reactor for cell expansion before recombinant viral infection. Use of 2000 L reactor for 900 L culture volume for recombinant viral infection. System used was adenoviral vector. Performed flow cytometry daily to obtain cell count in bioreactors (Nova).• Interfaced with the client and quality assurance (QA) consultants on a nightly basis to ensure the facility was headed towards cGMP compliance in the midst of an FDA issued 483 shutdown. Further interfaced with QA once consultants left to write Deviations, Effectiveness Checks, CAPA’s, and SIC’s.• Performed investigations into deviations and wrote deviation investigation reports. Performed batch record review as part of deviation investigations.• Co-Lead Corrective and Preventive Action (CAPA) Committee to ensure contract deviation authors were making good and reasonable improvements to the factory and processes• Designed a Logbook Tracker Spreadsheet (business tool).
