Posted by on December 06, 19100 at 14:23:20:
Stephen T. Thompson
419 Denise Street, Tarpon Springs, Florida 34689
Home Telephone: 727-938-1661 Office: 727-399-5318
Mr. Thompson has 30 years of increasing quality management responsibility for Quality Assurance/Control and Laboratory Systems, Validation, Sterilization, Regulatory Affairs, Project Management and Process Optimization. Established experience in the Medical Device, Biopharmaceutical, Pharmaceutical, and Diagnostic Biomedical health care products industry. Mr. Thompson resides in Tarpon Springs, Florida and is the Manager of Laboratory Services at Linvatec Inc. located in Largo, Florida. Linvatec is a leading manufacturer of arthroscopic surgical instruments. Previous international working assignments include living and working in the Republic of Singapore and Sweden.
The diversity of previous positions and projects are indicative of his capabilities to provide solutions that are practically sound, technically state-of-the-art, and in step with regulatory agencies. His efforts can be shown to have moved each of his prior companies forward. His successes are due to an ever increasing technical background, a knowledge and appreciation for effective team building, fundamental principle centered leadership and sound fiscal responsibility.
Career Highlights
Quality and Laboratory Management - Currently he manages in-house and contract laboratory chemistry, microbiological and biocompatibility testing programs including sterilization validation for Linvatec. While employed at Corixa, Inc. (formerly Anergen, Inc.) where he was Manager of QA/QC, he undertook and completed the task of building the Quality unit function through start up, development and IND submission phases of the company's development. The Quality Systems established include; Document Control, QC Laboratory, Incoming Materials Inspection and Manufacturing QA, Facility/Equipment/Process Validation, Vendor Quality Program and IND submissions (CMC) section preparation. At Nutek, Inc. and Alamar Biosciences He undertook and was successful in establishing and implementing similar Quality and Regulatory functions. As a consultant, provided systems for the establishment of quality system functions for start up medical device product clients. The majority of experience has been working within established Quality Systems for major health care product manufactures.
Validation - International responsibility at Becton Dickinson, (formerly Ohmeda) for determining and executing corporate policy for sterilization and laboratory validation for Europe and Asian operations. Construction and validation of utilities/facilities/equipment for a pilot plant designed for mammalian cell culture and affinity/ion-exchange chromatography protein purification, process validations for the manufacture of small molecule drug substances (peptides) and production of monoclonal antibodies and aseptic processing of finished pharmaceuticals at Anergen. Sterilization processes validated include radiation (gamma & electron beam), ethylene oxide, steam and dry heat. Developed and validated gamma and electron beam irradiation processes of Abbott Laboratories and Ohmeda (BD) using ANSI/AAMI/ISO Standards. Validation of WFI and supporting utility systems at Sterling Drugs in their small volume parenteral facility including media fill process validation to support aseptic processing of drug products. Preparation, review, approval and execution including summary reports of validation/qualification protocols.
Regulatory Affairs - Preparation of IND submissions (CMC) section for Biopharmaceuticals submitted to FDA-CBER for the approval of small (peptides) and large (proteins) molecule products. As a consultant, Drug Master File (DMF) preparation and review for a synthetic peptide bulk drug substance. As Director of RA/QA at Alamar Biosciences, prepared, submitted 510 k submissions and received FDA approval of the initial Gram Negative Antimicrobial Susceptibility (MIC) Diagnostic Test Systems.
Project Management - Planned and directed laboratory and sterilization validations for irradiation and ethylene oxide for Becton Dickinson throughout Europe and Asia. Participated and/or directly responsible for the management of validation projects for utilities, equipment, systems and processes for Biopharmaceutical, Drug and Medical Device products. Developed and maintained time lines for validation and related projects. Coordinated project activities at contract manufacturers for the manufacture of critical raw materials, bulk drug substances, and finished products.
Professional Experience
Linvatec Inc. Largo, FL June 1999 to present
Title: Manager, Laboratory Services
Linvatec manufactures equipment for Artroscopy surgery utilizing least invasive orthopaedics and endoscopy procedures and instruments. The electronic power system consoles provide power for hand held cutting, resection and electrosurgical instruments. Linvatec also provides sterile disposable resection and electrosurgical devices. Responsible for all sterilization validation and laboratory testing to assure the application of scientifically sound and validated procedures are utilized.
Becton Dickinson, Singapore and Sweden (formerly Ohmeda) February 1996-May 1999
Title: Director, Laboratory Services
Responsible for the development and execution of international validation strategies for sterilization processes. The qualification of laboratories and manufacturing support systems including construction of laboratory and manufacturing cleanrooms, process water systems and compliance assessment. Manufacturing locations include the Germany, Sweden, United Kingdom and Singapore.
Corixa. Redwood City, CA (formerly Anergen Inc.) June 1992-April 1995
Title: Manager, Quality Assurance and Quality Control
Responsible for the management of the Quality Unit function and to assure the implementation and maintenance of Quality Systems including Good Manufacturing Practices. Using biotechnology, Anergen was developing proprietary therapies for the treatment of autoimmune diseases.
Nutek, Inc. Palo Alto, CA July 1991-April 1992
Title: Manager, Radiation Applications
Nutek is a contract sterilization company specializing in Electron Beam irradiation technology serving the Biomedical products industry. Responsible for Electron Beam processing and validation applications, including the preparation and execution of protocols designed for client’s products and requirements.
Alamar Biosciences, Inc. Sacramento, CA November 1990-July 1991
Title: Director, Regulatory Affairs and Quality Assurance
Responsible for establishing and directing the Regulatory Affairs and Quality Unit functions. Preparation, submission and approval of 510(k) submission seeking approval of Antimicrobial Susceptibility Diagnostic (MIC) test products. Preparation and execution of utility, equipment and process validation protocols.
Abbott Critical Care, Mountain View, CA October 1984-November 1990
Title: Manager, Quality Assurance and Quality Control Laboratory
Abbott manufacturers electronic flow control infusion pumps and cardiac monitoring systems, which include sterile pulmonary arterial catheter systems. Responsible for QC Lab, Incoming Materials QA in addition to the development and validation of sterilization processes.
Sterling Drug, Inc. McPherson, KS July 1983-September1984
Title: Manager, Manufacturing Quality Assurance, Microbiology and Pharmacology
Sterling manufactures both small and large volume parenteral drug products using aseptic processing terminal sterilization, and lyophylization.
Norwich Eaton Pharmaceuticals, Norwich, NY (now P&G) August1978-June 1983
Title: Manager, Microbiology and Incoming Materials QA
Johnson & Johnson Baby Products Company, Skillman, New Jersey
Title: Manager, Microbiology and Technical Services Laboratory September 1976-August 1978
Johnson & Johnson Products Company, Sherman, Texas October 1975-September 1976
Title: Manager, Quality Assurance Microbiology
Weber County Health Department, Ogden, Utah October 1974-October 1975
Title: Environmental Health Specialist
Cutter Laboratories
Title: GMP Compliance Auditor, Ogden, Utah October 1973-July 1974
Title: Supervisor, Microbiology Laboratory, Chattanooga, TN May 1972-October 1973
Title: Quality Control Microbiologist, Ogden, Utah October 1969-May 1972
Education
BS Degree-Microbiology, Weber State University, Ogden, Utah, 1970
Membership
Association for the Advancement of Medical Instrumentation, AAMI
American Society for Quality, ASQ
Presentations
ASQ, San Francisco Bay Area Biomedical Discussion Group Program Chairman for the joint meeting with the Northern California Discussion Group (NCPDG) "Biotechnology Regulatory Update" March 1995.