Management Manager
Resume:
Roger Dabbah, PhD, MBA
*******@*******.***
Pharmaceutical/biotechnology senior scientist and director with expertise in management, program planning, strategic planning of R & D, and project management in QA.QC, technical services laboratories, and management. Technical and regulatory expertise in the pharmaceutical/food industry in analytical, bioanalytical, and processing systems for small and large molecules, including sterilization, aseptic processing and various dosage forms. Provided microbiological audits of environmental microbiological testing and responded to FDA 483s. Just completed a 7 weeks consultation for environmental microbiological issues in a pharmaceutical plant in Long Island, NY under the aegis of Quintiles. From May 2017 t0 August 2017 was a QA/QC consultant under a contract from RAC. Expert witness for major organizations for patents and other technical issues.
SUMMARY OF QUALIFICATIONS
1. Experience in the food and pharmaceutical industry in R & D, QA/QC, and technical services. Experience at the US Pharmacopeia developing standards for quality, identity, purity of small and large molecules. Experience in drugs, biotech derived products, medical devices and biocompatibility, and dietary and Nutritional Supplements. Experience in troubleshooting in plants for microbiological environmental issues.
2.Management of Laboratories with manpower of 120+. Management of Volunteers Expert Committees.
3.Expert in microbiological issues, testing, sterilization, troubleshooting in plants
4.Expertise in the quality of animal and plant derived products, chemical drugs as well as biotechnology derived products, including gene and cell therapy
5. Strategic planning of R & D and QA, in program planning, and especially in project management
6.Establishment of internal bridges between R & D and the other functions of the enterprise. Established bridges with national & international organizations
7.Establishment of liaison with external stakeholders in academia, government, and industry.
8.Patent expert witness
9.Close collaboration with FDA in setting quality standards for the US Pharmacopeia.
10.Regulatory remediation
Professional Experience
University of Maryland, University College, Graduate School (1986 to present), Adjunct Professor in Technology Management:
1.Teaching Face-to-face and online
2.Course on Project Management
3.Course on Risk Management in projects
4.Courses in Marketing, Strategic Management of R & D, Human Resources Management, Technical Planning, Management of Innovation
Johns Hopkins University, Whiting Graduate School of Engineering-Practitioner Faculty (1986 to present)
1.Teaching Face-to-face and online
2.Course on Project Management
Tri- Intersect Solutions, Potomac, MD (2006 to present)
Principal Consultant & CEO
1.Development and delivery of seminars organization dealing with microbiological quality assurance, sterilization, and harmonization of microbiological and biotechnological standards and procedures among the US Pharmacopeia, and the Pharmacopoeias of Japan and Europe.
2.Development and presentation of one day seminar to Dow Pharmaceuticals on various issues of quality control and microbiological testing and environmental testing
3.Webinars on Sterility testing and Rapid methods for microbiological testing
4. Technical expert witness for legal cases involving major organizations
5. Remediation for pharmaceutical/biotech organizations.
Provided microbiological support to organizations responding to FDA483s on environmental microbiological issues. Developed responses to FDA and audited the environments and the microbiological laboratories for compliance to SOP and developed a program for updating of SOPs.
US Pharmacopeia, Rockville, MD, Director, Division of Complex Actives
1.Analysis of new technologies to position USP in the future. New technologies included “omics”, gene and cell therapy, genetic testing, personalized medicine, stem cells, bioinformatics, PAT and nanotechnologies. Provided recommendation to the Board of Directors of USP and the steering committee of the expert committee. Managed the development of USP Chapter on Gene and Cell Therapy with a Gene Therapyy expert committee.
2.Technical, managerial, administrative, and budgetary leadership of expert committees involved in the development of standards for small and large molecule products in microbiology, sterilization, biotechnology –derived products, vaccines, blood and blood products, cardiovascular drugs, veterinary drugs, pharmaceutical waters,, antibiotics and antiviral, medical devices, toxicology and biocompatibility for containers and plastics that are used by FDA for compliance audits.
3.Development and implementation of a biotech laboratory for cell cultures, PCR and physicochemical characterization of products. Initiation and presentation of a business plan for the biotechnology initiative, including the development of new lines of reference standards to expand pharmacopeial business opportunities.
4.Harmonization of microbiological requirements and biotech requirements with the Pharmacopoeias of Europe and Japan.
5.Design and implementation of a program for the development of new lines of reference standards.
6.Represented USP to US Advisory Groups to ISP/TC 194, 76, 198, 209, and 239. Represented USP at AAMI, PDA, ANSI, ASTM and the WHO Biological Standardization Committee in Geneva.
7.Developed the USP Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
Department of Public Health, State of Illinois - Chief of the Laboratory Division
Short term assignment to reorganize the laboratory division to make it more responsive to crisis such as the Tylenol poisoning issues and salmonella contamination of dairy product. Managed three state laboratories doing analytical work on food, drugs, cosmetics, HIV lab, and environmental contaminants. The laboratory division included analytical, bioanalytical, microbiological and toxicological procedures. Completed the reorganization.
Controlled Release Technology, Oakbrook, IL Vice-President of R & D
Development of Business plan for a start –up corporation for first round funding from venture capitalists. First Round of financing obtained.
Baxter Healthcare, Deerfield, IL - Corporate Director of Microbiology, Sterilization & Immunology
1.Parametric Release of Steam and ETO sterilized products
2.Technical, administrative and budgetary responsibility for a division of 120+ scientists and support personnel
3.Development and implementation of strategic planning for R & D divisions and development of a system to identify opportunities based on a 3-D approach
4.Initiated a program planning system for R & D and QA
5.Servicing all R & D divisions for microbiological and sterilization and immunological issues including QA issues
6.Provided troubleshooting in plants in QA/QC and technical services
Abbott Laboratories, Nutritional Division, Columbus, OH
Manager- R & D Administration, Manager Biological Sciences and Information Sciences, Manager of QA Microbiology-Research and Services
1.Administrative and budgetary and strategic planning responsibility for the R & D Division
2.Development and implementation of program planning for R & D based on zero-based budgeting approaches
3.Trend analysis system for quality of raw materials
4.Development and implementation of a rapid sterility test for infant formula
5.Management of QA microbiological services and research laboratory and of scientific information systems and statistical analysis
USDA-ARS-Field and Crops-Dairy branch
Research Microbiologist
1.Development of microbiological quality parameters for milk intended for Manufacturing purposes
2. Heat Resistance and recovery of microorganisms in milk and egg homogenates
3.Development of milk flavored with citrus oils to extend shelf life
4.Salmonella testing
EDUCATION
PhD, Food Sciences/Biochemistry, U of Maryland, College Park
MBA, General Management, U of Dayton, Ohio
MS, Dairy Microbiology/Public Health, U of Minnesota, St Paul, MN
BA, Bacteriology/chemistry, U of Minnesota, Minneapolis, MN
OTHER INFORMATION
On the editorial Board of Pharmaceutical Technology and was on the Editorial Board of BioProcess International
Presentations to national and international scientific meetings and papers, articles, chapters in books published
Author of two books, one on “Total Project Management-Strategies and Tactics for the Healthcare Industries” (1993) and one on “Total R & D Management-Strategies and Tactics for the 21st Century Healthcare Manufacturers” (1999)
Bi-lingual in French and English.
SELECTED PUBLICATIONS
Dabbah, R., Drug Approval Process and Regulatory Requirement, in Pharmaceutical Analysis for Small Molecules, Behnam Davani, edit., Wiley & Sons, August 2017
Dabbah, R., Pharmacopeias and Compendial Approval Process in Pharmaceutical Analysis for Small Molecules. Behnam Davani, edit., Wiley & Sons, August 2017
Dabbah, R., The Management of Analytical Laboratories in Pharmaceutical Analysis for Small Molecules. Behnam Davani, Edit., Wiley & Sons, August 2017
Dabbah, R., Microbiological Methods Analysis, in Common Methods in Pharmaceutical Analysis, inn Pharmaceutical Analysis of Small Molecules, Behnam Davani, Edit., Wiley & Sons, August 2017
Dabbah, R., Management Issues in the Microbiology Laboratory, in Laboratory Design-Establishing the Facility and Management Structure, Scott Sutton, Edit. PDA, Bethesda, MD and DHI Publishing, River Grove, IL, 2010
Dabbah, R.and D. Porter, Microbiology of Sterilization Processes, in Validation of Pharmaceutical Processes, Third Edition, J Agalloco & F. Carleton, edit, Informa Healthcare, NY., 2008.
Dabbah, R., and D. Porter., Validation of Microbiological Methods, in Validation of Pharmaceutical Processes, Third Edit., J. Agalloco & Fr. Carleton, Informa Healthcare, NY, 2008
Dabbah, R. Practical Strategies and Tools for R & D Management-Managing the Critical Interactions with your Overall Organization, Bioprocess International, April 2007, p.26
Dabbah, R., USP Pharmaceutical Waters-Bulk Waters, Bioprocess International, March 2006
Dabbah, R., USP pharmaceutical Waters-II- Packaged Waters and Harmonization issues, Bioprocess International, April 2006
Dabbah, R., USP Pharmaceutical Waters- III- General Chapters, Bioprocess International, May 2006
Dabbah, R., A Gentleman, A Scholar, and a Friend, A Tribute to the passing of Dr. Mike Korczynski, PMF Newsletter, 2006
Bhattycharyya, L., Dabbah, R., Hauck, W., Sheinin, E., Yeoman, L., Williams, R., Equivalence Studies for Complex Actives Ingredients and Dosage Forms. AAPS Journal, 7(4), 2005
Bhattycharyya, L., Cecil, T.,, Dabbah, R., Roll, D., Schuber, S., Sheinin, E., Williams, R., USP council of Experts Executive Committee. The Value of USP Standards For Therapeutic Products. Pharmaceutical Research, 21(10), 2004
Dabbah, R.The Role of USP in Biological and Biotechnological Ingredients and Products. Pharmaceutical Technology, Feb.1, 2004
De Veau, I., Dabbah, R., Sutton, S. The USP Perspective to Minimize the Potential Risk of TSE Infectivity in Bovine Derived Articles used in the Manufacture of Medical Products. Pharmacopeial Forum, 30(5), 2004
Dabbah, R., Porter, D., Microbial Contamination Control in Parenteral Manufacture, in book edited by K.L. William, Baker and Taylor, 2004
Dabbah, R., Cell and Gene Therapy Products- A USP Perspective. PreClinica, July-Aug. 2003
Dabbah, R., Harmonization of Compendial Procedures. PreClinica, May-June, 2003
Knapp, J., Porter, D., Dabbah, R. Developing an Information Chapter in USP to Demonstrate Equivalency in Microbiological Methods. American Pharmaceutical Review, 5(2), 2002
Dabbah, R., Knapp, J.E.,The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals: A Five year Retrospective Leading to the Future. Pharmaceutical Technology, North America, 25(7), 2001
Sutton, S., Knapp, J., Dabbah, R., Activities of the USP Microbiology Subcommittee during the 1995-200 Revision Cycle. PDA Journal of Pharmaceutical Science and Technology, 55(1), 2001
Dabbah, R., Management of the Microbiology Function of Organizations, in Microbiology in Pharmaceutical Manufacturing, Editor, R. Prince, PDA/ David Horwood International Publishing, 2001
Dabbah, R., Grady, L.T., Pharmacopeial Harmonization in Biotechnology. Current Opinion in Biotechnology, 9(3). 1998
Dabbah, R., Controlled Environments in the Pharmaceutical and Medical Products Industry: A global View from Regulatory, Compendial, and Industrial Perspectives in Aseptic Pharmaceutical manufacturing II- Applications for the 1990s, edited by M. Groves and R. Murty, Interpharm Press, 1995.
Dabbah, R., Research and Development Management in the Pharmaceutical Industries: Issues and Applications, in Sterile Pharmaceutical Manufacturing-Applications for the 19990’s-Volume 1, Editors, M. Groves, Wayne Olson, M.. Anisfeld, 1991, Interpharm Press.
Dabbah, R., Cytotoxicity Proposals. Center for Alternatives to Animal Testing Newsletter, Johns Hopkins, 5(2), 1987
Pearson, F.C., Weary, M.E., Bohon, J., Dabbah, R., Relative Potency of Environmental Endotoxin as Measured by the LAL Test and the USP Rabbit Pyrogen Test. Progress in Clinical and Biological Research, 93, 1982
Pearson, F.C., Weary, M.E., Dabbah, R., A Corporate Approach to in-process and end-product testing with the LAL Assay for Endotoxin. Progress in Clinical and Biological Research, 93, 1982
Dabbah, R., Moats, W.A., Edwards, V.M., Survivor Curves of Selected Salmonella enteriditis serotypes in Liquid Whole Egg Homogenates at 60 C. Poultry Science, 50(6), 1971
Dabbah, R., Moats, W.A., Edwards, V.M., Heat Survivor Curves of Food-Borne Bacteria Suspended in Commercially Sterilized Whole Milk. I- Salmonella. J of Dairy Science, 54(11) 1971
Dabbah, R., Moats, W.A., Edwards, V.M., Heat Survivor Curves of Food-Borne Bacteria Suspended in Commercially Sterilized Whole Milk. II- Bacteria Other than Salmonella. J. of Dairy Science, 54(11), 1971
Moats, W.A., Dabbah, R., Edwards, V.M., Survival of Salmonella anatum heated in various Media. Applied Microbiology, 21(3), 1971
Dabbah, R., Edwards, V.M., Moats, W.A. Antimicrobial Action of Some Citrus Fruit Oils on Selected Food-Borne Bacteria. Applied Microbiology, 19(1), 1970
Dabbah, R., Moats, W.A., Mattick, J.F. Factors Affecting Resistance to Heat and Recovery of Heat Injured Bacteria. J. of Dairy Science, 25(5), 1969
SELECTED PRESENTATIONS
Dabbah, R., The Pharmacopeial Approach in the Microbiological Control of Aseptic Processing-A Global Perspective, 5th Annual Aseptic Processing of Sterile Drugs Products, June 17-18, 2009, Arlington, VA
Dabbah,R., Packaging & Aseptic Processing- A review of the regulations, Symposium, Boston, October 2-3, 2008
Dabbah, R. Introduction to Molecular Methods of Microbiological Analysis. Symposium on Rapid Molecular Methods for Pharmaceutical Manufacturing, Boston, MA September 2008
Dabbah, R, Pharmaceutical Waters-An Update, Conference of Pharmaceutical & Power Generation Water Treatment, East Brunswick, NJ September 2008
Dabbah, R. Workshops of Pharmaceutical Water Preparation I & II, East Brunswick, NJ September 2008
Dabbah, R., Validation of Alternative Microbiological Methods. IVT Method Validation Conference, Philadelphia, PA, Dec 7, 2005
Dabbah, R., Validation of Microbiological Methods in USP. IVT Method Validation Conference, Philadelphia, PA, Dec.8, 2005
Dabbah, R., USP update on Biological and Biotechnology- Gene and Cell Therapy. First Latin American Congress on Microbiology, Buenos Aries, Argentina, Nov.7, 2005
Dabbah, R., Pharmaceutical Waters in USP. First Latin American Congress on Microbiology, Buenos Aries, Argentina, Nov. 8, 2005
Dabbah, R.,The Role of USP Microbiological Standards from Product Development to Marketing. First Latin American Congress on Microbiology, Buenos Aries, Argentina, Nov. 9, 2005
Dabbah, R., Harmonization of Microbiological Requirements. First Latin American Congress on Microbiology, Panel Discussion, Nov. 10, 2005
Dabbah, R., The role of USP Standards in the Pharmaceutical Industry. Barnett Webseminar, Oct. 2005
Dabbah, R., Aseptic Processing-The Pharmacopeial Perspective. Aseptic Processing and Sterile Processes Conference, Washington, DC, April 2005
Dabbah, R., USP Perspectives in the Transition from Small Molecules to Complex Molecules. IRR Conference on Follow-on Biologics, Washington, DC. April 2005
Dabbah, R., Review of USP trends for Rapid Microbiological Tests in the Pharmaceutical Industry. 7th Annual Advancing Technologies in Rapid Methods for Pharmaceutical Manufacturing, Washington, DC, Feb. 2005
Dabbah, R., Equivalence of Biotechnological Substances and Products.
WillBio conference on Characterization and Comparability for Complex Biological Products, San Diego, CA, Jan.2004
Dabbah, R., Harmonized Analytical Techniques Used in Biotechnology. AAPS National Biotech Conference, May 2004
Dabbah, R., Bulk and Finished Product Testing- Conventional and non-conventional Methods. AAPS Workshop on Future direction in Aseptic Processing, Moderator of Session, Arlington, VA, Dec. 2003
Dabbah, R., Rapid Microbiological Methods. PDA Audio Conference, Feb. 2003
Dabbah, R., Activities in Standardization of Cell and Gene Therapy Products. Korean FDA Symposium on Gene and Cell Therapy, Seoul, S. Korea, 2003
Dabbah, R., Perspectives on Comparability- A Global View. Symposium on Development of Biologicals, Basel, Switzerland, 2002
Dabbah, R., Development of Pharmaceutical Requirements for Biological and Biotechnological Products- Keynote Address, Interact 2002, Sydney, Australia, July 2002
Dabbah,R. Pre- and Post-market Evaluation and Regulation of Diagnostic Microbiology Devices. ASM Annual Meeting, May 1993.
Dabbah, R., USP Current Updates. PDA/FDA Meeting, Washington, D.C., September 1993.
Dabbah, R. The Role of Standard Setting Bodies in Biological Standardization- The USP Perspective. PMA Biological and Biotechnology Section Annual Meeting, Washington, D.C., September, 1993.
Dabbah, R., Harmonization of Standards for Biotechnology Derived Products. International Open Conference- The European Pharmacopoeia, Verona, Italy, April 1993
Dabbah, R., Alternatives to Animal Testing in USP: Past, Present, and Future. Pharmaceopeial Forum,, 18(6), 4416-4418, 1992.
Dabbah, R., Clean -rooms and Clean Zones: The USP Proposal. PDA/IES Joint Conference on Clean-Rooms and Microenvironments Technical Conference, Panel on Regulations, February 1992.
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