Francis B Smith III
• 9 Waban Ave , Worcester, MA 01604-2020
• Phone: 508-246-5463
• E-mail: smithfb3@gmail.com
• www.linkedin.com/in/francisbsmith/
Summary:
Senior Manufacturing Associate with 17 years in GMP Bio-tech/Pharmaceutical industry.
Expertise in fermentation and Purification, Bullet to bottle Manufacturing. Proficient at training,
documentation improvements, deviation and CAPA investigations.
EXPERIENCE:
Lonza Biologics, Hopkinton, MA
Senior Manufacturing Associate (2nd shift, Upstream)
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2009–2013
Executed hourly sampling and monitoring using Conductivity/pH meter,
Spectrophotometer, YSI, LIMS and PI historian.
Performed CIP and SIP using automated, semi-automated and manual systems.
Trained employees on aseptic manipulations & shake flask inoculation in BSC.
Experienced in aseptic bacterial cell culture, shake flask inoculation, 200 liter seed
reactor 2K liter bioreactor, harvest centrifugation and depth filtration using Delta V HMI
system.
Actively performed first level review of manufacturing batch records and logbooks to
support the reduction of deviations and QA observations.
Collaborated with other departments to insure all buffers, media and supplies are
available or ordered in SAP when needed for process operations.
Investigated deviations, ensure all information is captured properly, edit for clarity and
ensure timely approval, using Trackwise®, reducing QA backlog.
Initiated improvements to SOP's, Logbooks and Batch records as discovered, Using
DMS, reducing mistakes and deviations.
Authored process spreadsheet with time-lines for each step of the protein manufacturing
process, create a process time-line, allowing on-time ordering of materials and supplies
and eliminating the need to remake expired buffers.
Filmed training videos on equipment and gowning procedures, drastically reducing the
time it took to train employees on unfamiliar equipment.
Organized all SOP's used in each Manufacturing Suite, all SOP's on were immediately
changed upon revision, ensuring suites were always in compliance.
Generated a safety walk through sheet, bringing potential problems and safety issues to
light, and eliminating safety incidences within the Suite.
Abbott Laboratories, Worcester, MA
Senior Manufacturing Technician (2nd Shift, Upstream, Downstream)
2007–2009
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Experienced in aseptic Mammalian & CHO cell culture fermentation, harvest
centrifugation, depth filtration, purification, Ultrafiltration, Diafiltration, and sterile final
fill. Followed the process “Bullet to Bottle”, reducing staff, streamlining operations.
Executed daily sampling and monitoring using Conductivity/pH meter, BGA, YSI,
CEDEX and SAP.
Composed manual on operation and troubleshooting equipment reducing training time
on complicated equipment.
Francis B Smith III
Alexion Pharmaceuticals, Inc., Smithfield, RI
Manufacturing Associate III (Downstream)
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2004 – 2005
Photographed microbial samples before, and after processing, improving customer
understanding and satisfaction with final report.
Composed training documents on laboratory equipment and procedures, improving
employee understanding of complicated processes and procedures.
Cetek, Marlborough, MA
Instrument Operator III (2nd Shift)
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2005 – 2007
Purified antibody products using affinity column chromatography for us in human
lymphoma vaccine.
Aseptically conjugated cancer proteins to target protein for use in human vaccine.
Aseptically filled vials under clean room Class 100 environment.
Instructed new employees in Class 1000 clean room gowning, working in Class 100
HLAF hood, vaccine manufacturing, and administrative duties, improved employees
understanding of the process before, during and after training.
Authored cGMP SOP's, Equipment specifications and Material specifications, allowing
upper management to focus on higher level issues.
Altran Corporation, Boston, MA
Laboratory Technician
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2007 – 2007
Performed large scale downstream protein purification including Protein A resin and
Q-Sepharose resin, viral filtration, and tangential flow filtration systems.
Collaborated with engineers, vendors and employees on equipment, Suite layout, and
P&ID's, sped up the large scale purification equipment qualification process (IQ, OQ,
PQ).
Consolidated material specifications, SOP's and Batch records in new manufacturing
facility, streamlined SOP and Batch record approval.
BioVest International, Worcester, MA
Purification Associate II (Downstream)
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2001 –2004
Created a manual with all the common problems encountered with High throughput
screening equipment, with troubleshoot issues and solutions, reduced downtime and
increasing the number of samples run per shift.
Instituted a log on each machine's "hits", negative controls and problems, decreasing
training time on new assays.
Experience at using Robotic High-Throughput equipment using capillary
electrophoresis, robotic liquid handling equipment and TECAN.
EDUCATION:
Bridgewater State College, Bridgewater Massachusetts
Bachelor's of Science Degree in Biology
Francis B Smith III
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COMPUTER AND EQUIPMENT EXPERIENCE
• Delta V
• DMS
• GE Unicorn
• LIMS
• PI system
• SAP
• Trackwise©
• Alfa Laval centrifuges
• Beckman centrifuges
• Primo centrifuges
• Westfalia centrifuges
• CUNO filter systems
• Pall Stax Capsule system
• Palltronic Flowstar integrity tester
• Zeta Plus filter system
• New Brunswick incubator shaker
• Process tanks 300L up to 6000L
• Fermentors 200L up to 2800L
• Sani-matic CIP system
• Climate laser particle counter
• Mettler Toledo pH & Conductivity Meters
• Mettler Toledo pH, DO & Redox transmitters
• Millipore UF/DF skid
• NovasSeptum sampling devices
• Sartorius biowelder
• SAS Viable air sampler
• SciLog Flowmeter pumps
• SMA Microbial air sampler
• Thermo Scientific Mass spectrometer
• Ultrospec Spectrometers
• YSI Biochemical Analyzer