2008 to

(Undisclosed)

Principal

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.

2007 to 2008

Lonza BioScience, Inc.

Engineering

Vice Pres./Global Head of Engineering

•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.

2004 to 2007

Manufacturing Automation Corp.

Engineering

Director, Technical Operations

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.

2003 to 2004

Progenitor Cell Therapy, LLC

Engineering

Director, Engineering

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.

1989 to 2003

Osteotech, Inc.

Corporate Engineering

Director of Engineering

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.

1976 to 1989

Ethicon, Inc. (Johnson & Johnson).

Engineering

Manager, Plant and Project Engineering

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.

• 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.
• He 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 for consulting on EO sterilization and microbiology needed for Class III medical device.
• EO sterilization expert specialist for 3rd party review of facilty.
• Sterilization expert for consulting on SIP/CIP for mechanical seals and media mill grinding of industrial equipment for the bio industry.
• Expert medical manufacturing for consulting on starting a medical manufacturing facility.
• Expert in hydrogen peroxide vapor sterilization for consulting on H2O2 sterilization of aseptic process equipment.
• FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
• Expert sterilization etho for consulting on ETO Sterilization.

• Sterilization expert for consulting on a sterilization process trade secret.
• Tissue expert for consulting on cervical spacers.
• Expert in FDA litigation for consulting on microbiological contamination of pharmaceuticals.
• Expert in medical devises for consulting on failure analysis of Endologix Powerlink catheter (SMDA).