Manufacturing Plant

Thomas W Anderson

** ***** ******. *******, ***** Island 02886 401-***-**** email: **********@*******.***

Core strengths:

• Extensive experience in the Biopharmaceuticals Industry.

• P&ID’s (Piping and Instrumentation Diagram) Working Knowledge SOP,s, cGMP.

• Cell Culture, Pilot Plant, Inoculation area, Glass wash, Media and Buffer Prep.

• Safety Compliance, Engineering Support,Validation skills

• Aseptic technique, Bio Safety cabinets, Laminar flow hoods, Autoclaves, Drying Oven’s, Homogenizer, UF skid

• Millipore filter press, centrifuge

• Word, Excel, PowerPoint, Unicorn, Lims, Delta V,YSI, BGA, pH & Cond. Meter, Scales, Cell Counting

Experience:

Lonza Biologics Inc. Hopkinton, Ma 01748 May 13, 2013 to Sept 27 2013

Manufacturing Technician (Contract Worker)

• Gowning

• Clean Room

• Scales, pH/Cond meters, Filter integrity Tester,

• Wrapped items for Autoclaving, Depyrogenation

• Hand wash of equipment, CIP, SIP

• Preparation of small scale solutions/Buffers.

• Aseptic processing of small scale solutions.

Alexion Pharmaceuticals Smithfield, RI February 12, 2007 to March 6, 2012

Manufacturing Associate III, in Cell Culture

• Vessels sizes worked with, 200L, 1500L, 10,000L

• Wrote new SOP’s using the P&ID’s (Piping and Instrumentation Diagram) and manuals for equipment.

• Assisted in the IQ, OQ, PQ validation of all Cell Culture equipment and process during start-up of facility.

• Started producing batches for conformance qualification for the FDA

• maintains clean room environment to comply with regulatory requirements

• Performed Decontamination of vessels as necessary.

• Performed CIP (clean in place), Pressure Holds, SIP (Steam in Place) of Bioreactors and Vessels.

• Performed daily samples of vessels using Nova sampling device, Nova Bio profile, Nova 100 testing unit,

manual cell counts.

• Aseptically work in the Inoculation area for cell scale up to 15L spinners.

• Performed large scale media transfers/filtration. Glucose and antifoam additions

• Performed Inoculated of 200L seed reactor from 20L spinner flasks.

• Performed harvest of the 10,000L reactors utilizing Centrifuge, Millipore filter skid and Ultrafiltration unit.

• Supported activities in the Pilot plant 200L reactor working out feed strategies for the Main suit and also batches

of new products for testing and patient trials.

• Assisted in Validation using Thermocouple placement, Biological indicators, rinse samples and spray ball

challenge.

• Initiate work orders Lims system.

• Participated on the safety committee and performed inspections of areas.

Abbott Bio-Research Center Worcester, MA 01605-4312 May 9, 2005 to February, 2 2007

Sr. Manufacturing Fermentation Tech I

• Vessels sizes worked with, 200L, 3000L, 10,000L

• Responsible for manufacturing of clinical and commercial products.

• Operated equipment such as bioreactors, centrifuges, filtration devices, chromatography equipment, washers

and autoclaves.

• Aseptic sampling of the USP water system Weighs and checks raw materials.

• Performed Harvest utilizing UF Skid, chromatography skid and cuno filters.

• Completes production records and maintains clean room environment to comply with regulatory requirements.

• Initiate Deviations from standard practices.

• Summit samples using Lims system

Amgen, Inc. West Greenwich, R.I. November 2001 to July 2004

Manufacturing Associate II in Buffer and Media Preparations

• Vessels sizes worked with, 200L, 3000L, 20,000L

• Advanced rapidly through positions of increasing responsibility and charged with the support of a production

team for this leading biotechnology company focused on the development of human therapeutics.

• Specific responsibilities include hands-on operations, setting-up, CIP, SIP and preparing media and buffers per

procedures.

• Define and coordinate daily buffer-prep work assignments in accordance with production deadlines while

assuming stand-in management responsibilities during supervisor’s absences.

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