Expert Details

Expert in Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization

Expert ID: 720664 New Jersey, USA

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Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation Corp.and Lonza, Inc. with over thirty years experience. He has supervised the construction and installation of several thousand square feet of clean room manufacturing area. His experience is in medical device manufacturing, involving the areas of packaging, filling, ultra pure water (WFI) and machine design.

Expert is a licensed professional engineer in New Jersey and Maryland.

Expert has extensive expertise in the manufacture of medical devices and biologics. Extensive experience in sterilization engineering and industrial sterilization processing and techniques using ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, and gas plasma sterilization. He has experience in ETO scrubbers and environmental monitoring. He is was involved with the very first peracetic acid gas plasma sterilizer.

Expert has extensive experience in the aseptic processing of human tissue for transplantation in addition to medical device sterilizaton techniques and processes.

Evaluation and implementation of predictable preventive maintenance programs, minimizing unscheduled downtime and maximizing maintenace and calibartion resources, all meeting FDA compliance requirements.

Experience in Master Site Planning. Leading planning activities, construction, commissioning and start-up of new FDA regulated facilities.

Expert has been a retained consultant, concentrating on assisting executive management; focusing on auditing, validation, process development, facility expansion and development plans, correcting adverse FDA and other regulating agency findings. He has interfaced with local, state, and federal regulating bodies on client’s behalf. Expert developed detailed Master Plans for implementation, budget for location and design of three aseptic processing facilities nationwide for processing of vaccines.Review of technical literature for litigation proceedings.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - Stamford, Connecticut - Philadelphia, Pennsylvania - Allentown, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1971 Degree: BS Subject: Mechanical Engineering Institution: City University of New York

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Principal Department: Medical Devices Responsibilities: Present Assignments:
Assisting a major (Fortune 10) pharmaceutical company in their research integration effort, that will bring approximately 300 researchers and support staff from various Bioprocess Development departments to one site. The project includes both renovations to an existing 1.1MM ft2 facility and a new 139,000 ft2. research facility. Project budget is $157MM.
Working with a Midwest biotech company processing purified DNA and Proteins. The challenge is to fully automate their filling, packaging and lyophilization processes in a new state of the art FDA regulated 150,000 ft2 facility.
Past Assignments:
Commercialization of a Multi-wave Ultrasound Elastography Breast Lesion Detection system. A new multi-wave ultrasound technology that provides imaging for precise, quantifiable results for early detection of breast cancer.
Clinical support for a Bone Ultrasonic Scanner ™ (BUSS) is an ultrasound device that can be used to screen, diagnose and monitor osteoporosis through multi-parametric assessment of bone mechanical and structural characteristics.
Assisting a start-up pharmaceutical company develop process, identify process equipment and meet regulatory compliance in order to begin manufacturing and bring API’s in-house.
Process Development: Providing technical support and knowledge based solutions to the Life Science Industry.
Research, Identify and Perform Due Diligence for external manufacturing and third party suppliers.
Site and Facilities Services: Plan, Design, and Build flexible, cost-effective and energy efficient processing areas and facilities all meeting Federal (FDA) Regulation and local codes.
Provide Flexible, Customizable Aseptic Processing solutions for all pharmaceutical, medical device and biologic producers conducting Phase 1, 2, or 3 clinical trials to scale up and commercialization capability.
Resolve compliance issues with FDA, EPA, State and Local authorities.
Years: 2007 to 2008 Employer: Lonza BioScience Inc. Title: Vice Pres./Global Head of Engineering Department: Engineering Responsibilities: •Member Leadership Sector Team report directly to President, Lonza Bioscience. Supporting sales of $2.87 billion. Support Lonza’s position as leading innovator and supplier of cell-based solutions for the global pharmaceutical and biopharmaceutical research markets.
•Responsible for four Domestic facilities and four International (Denmark, France, Singapore and Belgium) sites.
•Direct overall engineering and technical activities for the global organization, relating to the creation, development and design of the organizations products, and facility infrastructure.
•Head of Safety, Health and Environmental.
•Capacity is over 5 billion adherent cells per manufacturing lot.
•Lead all engineering activities and groups, site management maintain infrastructure, processing equipment, Master Site Planning, facility upgrades and new construction of aseptic cell therapy processing facilities.
Years: 2004 to 2007 Employer: Manufacturing Automation Corp. Title: Director, Technical Operations Department: Engineering Responsibilities: Responsible for directing activities involved in process development, new product commercialization, facility expansion, auditing and validation.
Develop Upfront process requirements and work closely with in-house and outside resources throughout project to assure requirements are met.
Responsible for Process Development for FDA regulated products and processing facilities from concept through validation.
Technical Development Lead on cross-functional multi-national new product development team. Developing the next generation disposable drug delivery systems, a needle-free injector designed for self-administration of a $3.5 Billion Ortho Biotech, Inc. (Johnson & Johnson) drug and a pre-filled Auto Injector device designed for self-administration of two new Centocor, Inc. (J&J) pharmaceuticals. Project budget was $28.1 Million. Product designed to meet Six Sigma quality requirements
Project Lead on a $7 Million EtO sterilizer project for Guidant, Inc. Develop a fully automated system with minimal human interface.
Researcher investigating novel sterilization sciences for a new micro woven product introduction from W.L. Gore & Associates, Inc.
Proven Knowledge and Experience necessary to implement technology ideas and concepts early in the project life cycle.
Interface with local, state and federal agencies on client’s behalf.
Define and Implement cost estimates, cost savings opportunities, utilizing Lean Manufacturing Techniques throughout the process development.
Manage and deliver complex projects across a variety of geographic, company divisions and functions.
Years: 2003 to 2004 Employer: Progenitor Cell Therapy, LLC Title: Director, Engineering Department: Engineering Responsibilities: Provide stem cell research and clinical services through a network of CGMP Aseptic processing facilities to medial products and pharmaceutical companies, assisting in their efforts to develop and market existing and emerging cell therapy products and treatments.
Years: 1989 to 2003 Employer: Osteotech, Inc. Title: Director of Engineering Department: Corporate Engineering Responsibilities: A global leader in the processing of human bone and connective tissue for the transplantation and an innovator in the development, manufacturing and marketing of biologic, biomaterial and device systems for musculoskeletal surgery. With a particular focus on spinal, trauma and total joint revision procedures, the company’s current and development-stage technologies address needs within numerous musculoskeletal disciplines.
Years: 1976 to 1989 Employer: Ethicon, Inc. (Johnson & Johnson). Title: Project Engineering Department: Engineering Responsibilities: A global medical device company and a leader in medical devices design and manufacture for more than 100 years with expertise in wound management, women’s health and cardiovascular surgery. Part of the world’s most comprehensive and broadly based manufacturer of health care products, it enjoys a reputation as the world leader in developing quality products to enhance the lives of patients and for providing outstanding service to customers. Presently conducts business in 52 countries and employs approximately 11,000 employees in its various worldwide locations.

Government Experience

Years Agency Role Description
Years: 2013 to 2016 Agency: U.S. Army Medical Research Institute of Infectous Deseases Role: Project Executive Description: Project Executive for the new 931,000 ft2 U.S. Army Medical Research Institute of Infectious Diseases facility at Fort Detrick, MD. Provide strategic leadership for the construction, equipment installation, validation, commissioning and startup. This CDC regulated facility is the premier biodefense laboratory for the Department of Defense and the cornerstone of the Nation’s interagency biodefense strategy. The facility incorporates the most stringent, state of the art biological high containment BSL2, BSL3 and BSL4 laboratories, clean rooms and vivarium. The project budget is $680MM.

International Experience

Years Country / Region Summary
Years: 1984 to 1988 Country / Region: South America Summary: Assisted in the construction of aseptic processing facilities.
Years: 1994 to 1996 Country / Region: France Summary: He worked on a tissue-for-transplantation processing facility.
Years: 2007 to 2008 Country / Region: Denmark/UK/Belgium/ Summary: He had responsibility for technical operations and facilities, supporting manufacturing and R&D.

Career Accomplishments

Licenses / Certifications
He is a Licensed Professional Engineer in the State of New Jersey and Maryland.
Awards / Recognition
Expert received Ethicon's Vice President Award for development and innovation of new products, and twice received the Johnson & Johnson Quality Award for cost savings and product implementation. This is Johnson & Johnson's most prestigious award.

Additional Experience

Vendor Selection
Expert has experience locating vendors of: sterilization and sterilizers; clean rooms; machine shops able to fabricate very difficult and precise components and custom machine-design prototypes.
Marketing Experience
Medical Device Manufacturing, Terminal Sterilization Parctices, Processing of Human Tissue for Transplantation, Master Site and Facility Planning, Aseptic Processes.
Other Relevant Experience
He has experience in the scaling up of R&D products and projects into viable manufacturing processes. He also has an extensive aseptic processing, medical devices and background in machine design, component selection, machine shop practices, and prototype development.

Fields of Expertise

aseptic filling, aseptic packaging process, clean room, medical device manufacturing, clean room design, industrial sterilization, sterile processing, sterilization, sterilization engineering, sterilizer, human tissue, maintenance management, medical device sterilization, site planning, vapor phase hydrogen peroxide sterilization, peroxyacetic acid, controlled environment, gas scrubber, pump, sterilant, computer-aided design, sheet-metal fabrication, process-engineering filtration, electric motor selection, computer-aided mechanical design, water-jet machining, medical product packaging process, mechanical refrigeration application, mechanical power transmission, low-temperature vacuum seal, low-temperature refrigeration, low-alloy steel, vacuum measurement, microwave sterilization, manufacturing control, machinery, polymeric material sterilization, retrovirus, metal surface hardening, wound healing, mechanical valve, vacuum seal, vacuum-compatible material, ultrapure water, threaded fastener, surgical instrument, spring, sanitizing, pump selection, proximity sensor, pressure measurement, positive-displacement rotary pump, pipeline, pick-and-place robot, neonatology, moisture sensor, metal sizing, metal rolling, metal finishing process, metal machining, metal bending, mechanical engineering, linkage, irradiation, industrial process, industrial gas safety, humidity sensor, heat exchanger selection, gear, gear pump, fluid flow measurement, flowmeter, ethylene oxide environmental effect, dynamic vacuum seal, disinfection, cutting tool, conventional machining, commercial refrigerator, cam (device), biomedical device manufacturing

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