Validation and Regulatory Compliance Expert Consultant Resume
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Resume of BAB, Ph.D. Consultant
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  • Pharmaceutical
  • Chemical
  • Cosmetics

This expert has a Ph.D. in Chemical Engineering from Lehigh University.

This expert earned their M.S. in Chemical Engineering Practice from the Massachusetts Institute of Technology.

This expert has a B.S. in Chemistry from the Massachusetts Institute of Technology.

Validation and Regulatory Compliance Expert Consultant Resume

This expert specializes in operations, production, validation, and project management. Further expertise includes senior management, process engineering, R&D, finance, and business development. Other related areas of expertise include audit, gap analysis, and remediation of facilities and departments at top-tier pharmaceutical companies including those involved in consent decrees.

This associate offers expertise specific to management of facility and equipment projects with budgets from $2 million to $700 million, pilot plant development, manufacturing, and FDA regulations. Further areas of expertise include cGMPs, standard operating procedure (SOP) and manufacturing batch record (MBR) documentation, and adherence to NIH biosafety guidelines.

Specialization includes bacterial vaccines, fermentation, purification, filtration, and centrifugation. Other areas of specialization are precipitation, derivatization, conjugation, and clean-in-place (CIP). Other areas include sterilize-in-place (SIP), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Additional experience includes EEC guidelines, and HAZOP, fault-tree analysis, plant site debottlenecking, and vaccine debottlenecking. Other background and experience includes installation of part 11 compliant document tracking systems, designing / implementing new business processes, and technology transfer.

This associate has served as a problem-solver (patents, systems), excellent communicator, coach, mentor, and educator to entry level through CEOs.

Consultant, Kevin Kennedy Associates Inc.

Providing project management, chemical engineering, senior management, process engineering, regulatory compliance consulting and related expertise for a wide variety of clients.

 

Neose Technologies, Inc., Horsham, PA

Responsible for establishing and running the process engineering, development, pilot plant, manufacturing and validation areas of the company. Scaled-up, and installed the facility to make Neose’s first product, under FDA regulations, cGMPs, in less than 15% of the time and for less than 25% of the cost. Discovered a new raw material source, and employed new technologies to reduce product cost of Neose’s first product by two orders of magnitude; two U.S. patents and a European patent. Trained subordinates in tracking and installing capital projects, reducing time and cost of installations using project management software. Introduced automation, saving $300,000/yr. Wrote much of the standard operating procedure (SOP) and manufacturing batch record (MBR) documentation to run the facility under cGMPs. Developed, oversaw and conducted the cleaning validation. Developed cost models for all products that changed the focus of development efforts for the company to the areas that generated the greatest value.

 

Project Coordinator, Merck & Co., West Point, PA

Project Coordinator of many departments, providing process technical input regarding new products and processes. Led review of all Merck processes for adherence to NIH biosafety guidelines. Upgraded a facility to produce PedvaxHIB®, on time and budget following all relevant cGMPs, FDA, OSHA, and DER governmental regulations. Renovated the Pneumovax® facility to meet safety standards in handling 5000 L of ethanol. Sold project to management. Completed on time and budget. Initiated $150 MM Biotechnology Manufacturing Complex facility. Acquired work experience in cGMPs, validation, bacterial vaccines, fermentation, purification, filtration, centrifugation, precipitation, derivatization, conjugation, clean-in-place (CIP), sterilize-in-place (SIP), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), EEC guidelines, and HAZOP. Advised on technology transfer of Recombivax hepatitis B vaccine to Shenzhen, China.

 

Air Products & Chemicals, Inc., Allentown, PA

Responsible for R&D, Fischer-Tropsh synthesis, bubble columns, (7 papers), process development on air separation, LNG, liquid helium, sulfur recovery Claus cycles (U.S. patent). Product development of novel heat exchangers, safety design using HAZOP and fault-tree analysis, plant site debottlenecking resulting in a 250% increase in capacity with less than 1% capital expenditure, cost estimation of processes and equipment, business development, equipment costing and design, product pricing, energy conservation.

Three U.S. patents, One European patent, Seven papers

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