Manufacturing Associate
Resume:
Michael Onufrak
Walpole MA 02081
********@*****.***
Objective: Seeking a full time position in manufacturing within the life sciences, preferable in the upstream process of cell culture with responsibility, challenge, and to acquire new skills and growth within the field of biotechnology.
Experience:
2004 to Oct.2010 Genzyme Corporation Framingham/Allston, MA
Manufacturing Associate
Buffer and media preparation, both large and small scale, sterile and non-sterile to support cell culture and protein purification.
Knowledge of Fisher Rosemont RS3 and Delta V.
Weighing and Dispensing of raw materials.
Supervisory delegate sign off for Productions Records, Cip's, SIP's & MFG Pro.
Start-up of Bulk HA Purification Facility to include: CIP, SIP, and PQ Process validation.
Revision of SOP's and Batch Records to support scale up.
Worked with validation through the remaining OQ testing for the APV Homogenizer, Cooling Studies and Sweco drying vessel.
Performed purification steps in the GMP manufacture of sterile sodium hyaluronate acid to include: solvent precipitations, filtrations, vessel CIP and SIP.
Seprafilm/Sepremesh production to include: cleaning and set up of processing machines, involving Lee mixing vessel, casting machine, and sheet washer.
Courses attended: Track-wise, Smart Capa, Critical Thinking and Deviation Investigation training.
2003 to March 2004 University of New Hampshire Durham, NH
Laboratory Technician II - Organic Stockroom - Maintaining the organic chemistry stockroom and assisting faculty in preparing organic course labs. Responsibilities to include: Maintaining physical & operational aspects of Organic Teaching Laboratories; Ordering of Chemical supplies through various vendors: Billing and replacement of glass breakage; Student check in & out; Oversee and maintaining instruments in laboratories to include: NMR, GC, and Infrared Spectrophotometers; Hazardous waste collection and coordinating disposal.
1996 to 2002 Lonza Biologics Portsmouth NH
Senior Fermentation Operator - Supervisor in training, to include: Assigning daily tasks, planning production schedules, coordinating of in-suite maintenance, Author of SOPs, Co-authoring and Revising of Batch Records and Process Changes. Initiating Deviation/Investigating Reports and making Lot Review corrections for document close out. Interviewing potential candidates for new hire and conducting plant tours.
Leadership training and personal computer skills in Microsoft Office.
Upstream/Downstream processing in a cGMP environment from 1996 to 2002. Process controlled fermentation including Fed-Batch cultures within Air-lift Fermenters. Certified trainer in all areas of upstream cell culture to include: Media/Buffer make up & transfers, Inoculum thaws & Grow-up, Seed reactors to Production reactors, Centrifuge & Depth Filtration skids, Ultrafiltration / Diafiltration / Intermediate Filtration skids. Good mechanical aptitude for trouble shooting CIP/SIP systems.
Participated in modifications to existing equipment, which includes working with P&ID's, reviewing equipment specifications, consulting engineers, vendors, and salespersons.
Validation experience involved in the Start-up & Shakedown of operational systems using Protocols and SOP's @ Lonza Biologics.
Installation Qualification - Worked with P&ID's to ensure all components are installed correctly to include: Proper orientation, slope, and labeled correctly.
Operation Qualification - Checked operational code for accuracy using DCS simulators.
Performance Qualification - CIP's to include: Ensuring recommended flow-rates, pressures, and temperatures. Testing of samples for resistivity and conductivity requirements & TOC surface swabbing. SIP's to include: TC mapping of systems and placement of biological indicators with complete knowledge of the Kaye digi-strip. Media simulations & Product stability to include: Media holds to verify tank sterility, Jacket controls for proper operating temperature, and pH/DO controls of Bioreactors.
Education:
NH Technical College @ Stratham NH . Associate of Science in Biotechnology, 1996
Deans List for Academic Honors, 1995-1996
Northern Essex Community College @ Haverhill MA . Deans List for Academic Honors, 1994-1995
Portsmouth Naval Shipyard, Sheet-metal Apprenticeship, Honor Graduate, 1982-1986
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