Members

MAIK W. JORNITZ is the founder and principle consultant of BioProcess Resources LLC. With close to 30 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a world-wide basis, in particular in validation, integrity testing, membrane filtration of air and liquids. As Chair of PDA, Jornitz has been part of multiple PDA task forces, committee member and program chair. He is also member of ISPE, DIA, ASTM and ALSAC. Jornitz is the author and co-author of close to 100 professional papers. Additionally he is author and co-author of 9 books and 15 book chapters on membrane filtration, integrity testing, validation studies, regulatory requirements and single-use technologies. As faculty member of PDA TRI and Compliance Online, he trains industry members and regulatory authorities on a frequent basis. He holds close to 30 patents related to integrity testing, single-use processing and filter housing designs. Mr. Jornitz received his M.Eng in Bioengineering at the College for Advanced Technology in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.

mwjornitz@hotmail.com

BioProcess Resources LLC is connected to well known consultants of the pharmaceutical and biopharmaceutical industry, which will be able to support our clients in a broad variety of expert needs and requirements. Please find the current list below:

 

James Agalloco
Agalloco & Associates

JAMES AGALLOCO is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He has served as a chairman and member of numerous PDA committees. He is a member of USP's Microbiology and Sterility Assurance Expert Committee for 2005-2010. He is a member of the editorial advisory board's of Pharmaceutical Technology and Pharmaceutical Manufacturing and serves on the scientific advisory boards of Laureate, MEDInstill, VanRX, MODA and IPS. Agalloco is a frequent author and lecturer on the subject of sterilization, aseptic processing, process and computer systems validations.
Dr. James E. Akers
Akers Kennedy & Associates Inc.
Dr. JAMES AKERS President of Akers Kennedy & Associates, Inc., has over thirty years experience in the Pharmaceutical industry and has worked at various director level positions within the industry and for the last decade as a consultant. Dr. Akers served as President of the PDA from 1991 to 1993. Dr. Akers served as a member of the PDA Board of Directors from 1986-1999. Currently, he is a member of the USP Committee of Experts Microbiology, as well co-chairman of the PDA Isolator Technology Task Force, Aseptic Processing Task force and member of several recent program committees. Dr. Akers has lectured world-wide, and taught numerous pharmaceutical technology courses world-wide including training for the US/FDA. Dr. Akers has also authored eleven textbook chapters, edited a book on isolation technology, has a second book on isolator technology in preparation, and authored more than 100 technical and review articles on a variety of subjects including validation, aseptic processing, contamination control, environmental monitoring and control, biotechnology, isolator technology, sterilization and disinfection, sterility testing, media fill testing, HACCP analysis, pharmaceutical microbiology and regulatory compliance.
 
Herman F. Bozenhardt

Bozenhardt Consulting Services LLC

hermanbozenhardt@gmail.com

Mr. Bozenhardt is Principle of Bozenhardt Consulting LLC. He has 37 years of experience in       pharmaceutical, biotechnology and medical device manufactuirng, engineering and compliance. Mr. Bozenhardt's expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. This includes service on three consent decrees, and system efforts which include 10 EBRS/MES projects, 3 PAT projects and 8 SAP ERP projects. Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems. He has extensive experience in the manufacturing of vaccines via cell culture technology, human plasma derivation and egg based technologies. Mr. Bozenhardt developed 6 major automation master plans. Mr. Bozenhardt received his MSc in Systems Engineering formt he Polytechnic Institute of New York and his BSc in Chemical Engineering from the Polytechnic Institue of Brooklyn, NY. 

 

Phil DeSantis
DeSANTIS Consulting Associates
 
phil.desantis@desantisassociates.com
www.desantisassociates.com
 
Over 45 years of pharmaceutical industry experience in design, construction, start-up and validation of facilities and processes.  Subject Matter Expert for GxP compliance related to facilities, equipment and validation.  Recognized industry expert in sterilization, aseptic processing, process validation and clean utilities. Leader in the development and remediation of Quality Systems.   Experienced in capital project and consent decree management.
EDUCATION
M.S. Chemical Engineering, New Jersey Institute of Technology, 1978
B.S. Chemical Engineering, University of Pennsylvania, 1969
PROFESSIONAL AFFILIATIONS
Parenteral Drug Association (Science Advisory Board, National Program Committee, Water Systems Interest Group Lead, numerous Task Forces and Working Groups)

 

International Society for Pharmaceutical Engineering

James Fernandez
Fernandez & Associates
JIM FERNANDEZ is the Principal of Fernandez and Associates, a firm that supports biotechnology and pharmaceutical products throughout the development process and into commercialization.  In recent operations Fernandez and Associates has worked on contract manufacturing selection and due diligence, process development and transfer to new production facilities, process validation including analytical methods validation, and other production oriented technical operations.  Jim has held positions ranging from analytical method development to laboratory management and technology transfer management at a number of biopharmaceutical and pharmaceutical companies.  His firm has operated throughout the US and Europe in establishing pharmaceutical and biopharmaceutical production and preparing and submitting licensing documentation to US and EU authorities.  Jim received his BS in Biochemistry in 1976 from Cal Poly University, San Luis Obispo, CA and his MBA in 1994 from St. Mary's College in Moraga, CA.  He has served as a chairman and member of numerous PDA committees including PDA Science Advisory Board and Biotechnology Advisory Board.
Colleen M. Kennedy
Akers Kennedy & Associates, Inc.
Ms. COLLEEN KENNEDY, Vice President of Akers Kennedy & Associates, Inc., has over thirty years experience in the biological/pharmaceutical industry. She has experience with biological vaccine production and management, and the product/process improvements of these products. She also worked on the research and development of new biological products concentrating on the purification of proteins. As Manager of Technical Services and Validation departments, Ms. Kennedy was responsible for full project management including validation, calibration, change control and technical transfer. Ms. Kennedy earned a MBA in Management from Loyola University of New Orleans, and a BS in Biology from Ramapo College of New Jersey. She has conducted several training seminars on GMP compliance, validation procedures, and isolation technology both domestically and internationally
Russell E. Madsen
The Williamsburg Group, LLC
Mr. RUSSELL MADSEN is President of The Williamsburg Group, LLC, engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, regulatory liaison and general technical services. Prior to forming The Williamsburg Group, he had served PDA as Acting President and was Senior VP Science and Technology, responsible for the overall scientific, technical and regulatory affairs activities of the association.  These responsibilities included publishing internationally respected technical reports, writing consensus positions on proposed FDA and international regulations and guidance documents, developing the scientific content of PDA's meetings and forums, working with associations such as PhRMA, CHPA, AdvaMed, AAMI, GPIA, A3P and R3-Nordic to coordinate and harmonize technical activities, and involving FDA and other organizations bodies (e.g., USP, EMEA, ISO, PIC/S) in PDA technical committees. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb pharmaceutical, medical device, nutritional, and cosmetic operations, worldwide.  He was also employed by Sterling Drug, Inc., as an analytical chemist and in laboratory management. Madsen holds a B.S. from St. Lawrence University and a M.S. in Chemistry from Rensselaer Polytechnic Institute.  He currently is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, serves as a member of the USP Parenteral Products-Industrial Expert Committee, is a member of Pharmaceutical Technology's Editorial Advisory Board, and is Technical Documents Advisor to ISPE.
Dr. Michael J. Miller
Microbiology Consultants, LLC.
Dr. MICHAEL J. MILLER, President of Microbiology Consultants, LLC., is an internationally recognized microbiologist, subject matter expert and consultant in pharmaceutical and ophthalmic/contact lens care microbiology, Process Analytical Technology (PAT) and the introduction of next generation microbiological technologies including rapid micro methods. With over 20m years of experience, he has held numerous R&D, Manufacturing, Quality, consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc.Dr. Michael J. Miller has extensive experience in providing guidance to regulatory agencies on the understanding and acceptance of novel technology platforms for microbiology control, sterility assurance and PAT. He has developed strategies for regulatory dossiers and comparability protocols for new PAT technologies and rapid microbiological methods in support of the FDA GMPs for the 21st Century and Quality by Design (QbD) initiatives. Dr. Miller has also had a significant impact on influencing industry best practices for pharmaceutical microbiology through his technical leadership and consulting roles within professional organizations, such as the PDA and ISPE, as well as his external interactions with international Pharmacopoeias and regulatory agencies. He is routinely invited to speak and lead technical conferences and symposia in the areas of microbiology, PAT, new technology opportunities and regulatory change. He received his Ph.D. in Microbiology and Biochemistry from Georgia State University in 1988.
Dr. Scott van Wagenen Sutton
The Microbiology Network, Inc.
Dr. SCOTT SUTTON, owner of The Microbiology Network, Inc., has over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical, medical device, cosmetics and personal products industries with extensive publications and presentations. Contamination control, laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. He operates, The Microbiology Network (http://www.microbiol.org)an information source on the internet, which provides services to microbiology-related user's groups and supports the PMFList, a microbiology Email list (http://www.microbiol.org/pmflist.htm) and the PSDG Email list (pharmaceutical stability topics) (http://www.microbiol.org/psdglist.htm). View a more complete resume at www.microbiol.org/consulting.htm
 
 

 

 

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