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TLK Consulting, LLC February 2005 to Present
Providing consulting and project management for the development, design, validation and manufacture of pharmaceuticals and medical devices. Areas of expertise include:
· Process development, validation and quality engineering
· Medical device design and quality system development per ISO 13485:2003
· Risk Management per ISO 14971:2007
· Design and Process Risk Evaluation (DFMEA/PFMEA)
· Compilation of Technical Files for CE Mark Certification
· Management of contract manufacturing
· Cleanroom design, startup and validation
· Equipment procurement and validation
Projects include:
· Facilitate meetings with key individuals, create draft documents and a training program for the optimization of a medical device design control quality system. Further optimize the system 6 months after implementation.
· Create Technical Files for CE Mark Certification and International Dossiers.
· Update Risk Management procedures for medical device company to ISO 14971:2007 standards.
· Create and update Risk Management documentation to ISO 14971:2007 standards (including Design and Process FMEAs) for class II and III medical devices. Review and evaluate design verification and validation testing (including biocompatibility, stability, packaging design and validation, sterilization validation), and process validation and manufacturing procedures.
· Update and standardize product specifications to ensure measurable acceptance criteria.
· Perform a quality and technical review of validation protocols and reports for equipment and facilities of a biotechnology facility.
· Quality review of standard operating procedures for small molecule manufacturing process.
· Assist with due diligence of technical manufacturing issues for potential investor of injectable drug delivery system.
FeRx Incorporated (Company Closed) May 1998 to May 2004
Head of Manufacturing for the cGMP production, process development and distribution activities of a magnetic drug carrier and medical device used through Phase II/III human clinical trials for the treatment of primary liver cancer.
Associate Director
· Manage process development engineers and manufacturing operators.
· Control department timelines, operating budget and procurement of capital equipment.
· Establish contract manufacturers for medical device program, fill/finish of drug carrier and sterilization.
· Design and implementation of quality systems for manufacture of drug and device for multi-national product.
· Develop and execute design control procedures, create and maintain DHF and DMR, perform FMEA, design verification, design validation, design review and risk assessment of medical device.
· Submit data for IND amendments to support optimization of Magnetically Targeted Carrier (MTC™) product process and changes to device design.
· Design, startup and validation of production cleanrooms to ISO standards.
· Validation of container/closure systems and terminal sterilization (autoclave, gamma irradiation).
· Perform GMP and technical audits of pharmaceutical and device contract manufacturers and suppliers.
· Support clinical trial sites with drug, device and equipment supply, training on device use, technical support for device, and complaint handling.
· Write and review technical reports, investigations, batch records, production records and SOPs.
· Developed a novel compound leading to patent for ceramic based microcarriers.
· Characterized in-house reference standard.
Senior Manufaturing Manager 6/00 to 6/02
Scientist 5/98 to 6/00
Geneva Pharmaceuticals September 1994 to May 1998
Responsible for supporting Development and Production activities for the cGMP manufacture of generic, solid dosage products.
Process Development Scientist III
· Project lead for optimization of Production Tableting processes.
· Optimize in-process specifications for 200+ existing solid dosage products using SPC.
· Purchase and commission new equipment for Process Development laboratory.
· Project lead for implementation of Fette high-speed tablet presses in Production and streamline of Tableting process. Optimize Production Coating processes.
· Optimize products and prepare data for ANDA supplemental filings.
· Perform Process Validation and Cleaning Validation.
· Experimentally determine scale-up standards for blending processes.
· Troubleshoot and investigate production issues - Granulation, Blending, Tableting.
· Transfer new products from development to production, including scale-up and validation.
· Write SOPs and revise batch records.
Process Development Scientist II 9/96 to 2/98
Process Development Scientist I 3/95 to 9/96
Process Development Associate 9/94 to 3/95
Synergen (Company closed) 1992 - 1994
· Optimization of equipment for fermentation, cell processing, chromatography and diafiltration of lead product, IL1-RA
· Development of CIP and SIP systems, characterization of RO system
· Various activities including: Scale-up of process, economic analysis, preparation of campaign summaries, database development, process validation and process scheduling.
Process Engineer 4/94 to 8/94
Process Development Associate 2/92 to 5/93
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