`Resume
John C. Budzinski Ph.D.
1850 Lenape Road
West Chester, Penna. 19382
Cell (610) 357-0274,
EXECUTIVE SUMMARY
Over 30 years management, technical and business experience in R&D, Administration and Manufacturing with recent focus on all aspects of pharmaceutical outsourcing including consulting and serving as manufacturing representative. Strong knowledge of outsourcing processes, vendor capabilities, worldwide (including China) sourcing opportunities and regulatory requirements with many industry contacts. Audited more than 175 companies for manufacturing and regulatory suitability, including 60 companies in China. Broadly networked with other pharmaceutical professionals to outsource API, finished dosage, QA and packaging. Broad international experience and knowledge of pharmaceutical outsourcing to help create and manage capital conserving, highly cost effective, responsive and secure supply chains.
Career Experience:
John C. Budzinski, Ph.D. 1
Pharmaceutical outsourcing
Vendor identification/selection
Contract and price negotiations
Technical transfer and support
Strategic supply chain planning
Organizational development
Sales – APIs and Intermediates
Intellectual property management
Auditing for mfg. suitability
R&D Discovery and Process Dev.
John C. Budzinski, Ph.D. 1
Phelix Pharma Outsourcing Consultants, Inc.
Founder and Principal Consultant (2002 – Present)
Outsourcing consulting for large and small fine chemical, pharmaceutical and biopharmaceutical clients to identify and manage outsourcing suppliers for R&D and commercial supply of Active Pharmaceutical Ingredients (APIs), cGMP intermediates, finished dosage and unique raw materials Services to client organizations include: R&D process development, R&D sourcing, commercial sourcing, site evaluations, company due diligence, market intelligence, contract negotiations and expert witnessing. Staff training and assistance to increase outsourcing expertise and productivity.
Global Pharma Sourcing, LLC(Founded 2002)
Co-Founder with Dr. Phil Ma and Managing Director
Global Pharma Sourcing is a sales agent for suppliers of pharmaceutical intermediates, and API’s. Our suppliers are generally located in low manufacturing cost countries, especially China. We work with pharma companies and suppliers to pharma companies to identify sources of material that meet their R&D and commercial requirements. In addition, Global Pharma Sourcing, provides consulting services to companies wishing to learn more about sourcing from China.
DuPont Pharmaceutical Company (now Bristol Myers Squibb)
Senior Director, Strategic Sourcing (1993 to 2002)
RESPONSIBLE FOR:
-Commercial out-sourcing for intermediates and API’s
-Supply chain strategies and capacity planning.
-Contract and vendor relationship management
-Cost control/reductions for new and existing products.
-Vendor management to assure QA and RA compliance
-Vendor selection and vendor strategy to identify key suppliers
-Business Mgr. with P&L responsibilities. - warfarin API sales & finished dosage to 3rd parties
Director, Wilmington Area Site (1990 to 1993)
Facilities management for all 5 DuPont Merck Wilmington sites (1.3 MM sq. ft. of lab and office space, 100+ reports). Reduced costs by over 25% by streamlining facilities management of 6 lab and office locations into a single unit. Site capital and operating budget responsibilities covering all facilities, general services, HR administration, safety, health and animal resources.
E. I. DuPont De Nemours
R&D Operations Manager, Medical Products Dept. (1989 to 1990)
Managed two R&D lab sites (350M sq. ft., 60+ reports). Responsible for facilities, R&D Patent Liaison function, R&D training, safety, health and animal resources.
Senior Compensation Consultant, DuPont Corporate HR Dept. (1988 to 1989)
Developed pay and progression systems for DuPont technical professionals. Led Corporate Committee to define new position evaluation system for DuPont.
Senior Supervisor Process R&D, Agricultural Products (1983 to 1988)
Directed 20-25 scientists in development and technology transfer of new, cost effective manufacturing process routes for bulk actives -- process development, scale up from lab to pilot plant and technology transfer to internal or external contract manufacturers.
Laboratory Administrator, Agricultural Products Dept. (1982 to 1983)
Administrative resource to R&D Directors. Responsible for R&D budgets, Patent Liaison group, R&D administration and design of new R&D facilities.
Research Supervisor, Agricultural Products Dept. (1978 to 1982)
Directed group of 8-10 Ph.D. scientists in discovery of new crop protection chemicals. Led major part of sulfonylurea herbicide program, set new strategic direction for insect control program and developed aggressive patent strategies to protect inventions.
Patent Liaison, Agricultural Products Dept. (1977 to 1978)
Special assignment working between R&D and Legal to optimize intellectual property value through patent strategies, filing and prosecuting of U.S. and foreign patents.
Research Chemist, Biochemicals Dept. (1973 to 1977)
Organic synthesis targeted at discovery of innovative biologically active compounds for use as pharmaceuticals and crop protection agents -- synthesis of novel compounds, development of structure activity relationships and new synthetic route identification.
Academic Background
Postdoctoral Fellow, Arizona State Cancer Research Institute, Arizona State University (Prof. G.R. Pettit)
Isolation, identification and synthesis of natural products with antineoplastic and anti tumor activity from marine organisms.
Ph. D. Organic Chemistry, Washington University,
(Prof. A. G. Hortmann)
Dissertation on novel synthetic methods, terpenoid biosynthesis with discovery of a novel monoterpene rearrangement.
B. A. Chemistry, Washington University, St. Louis, Mo.
Editorial Board - Pharmaceutical and Bio-Pharmaceutical Outsourcing, PharmaSource
Recipient – 1999 Summit Award - DuPont Pharmaceutical’s highest award of excellence for advancing technical and business goals for Sustiva™.
Six U. S. patents, with multiple foreign equivalents
Outsourcing Lectures and Publications
Working With Contract Manufacturers: Technology Transfer, Validation and Managing for the Long Term, Technology Transfer Symposium June 22-23. 1998, Philadelphia, PA.
Choosing and Working with API Contract Manufacturers, Outsourcing Pharmaceutical Manufacturing for Pre Clinical and Commercial Materials, September 14-15. 1998, Princeton, NJ
Avoiding "The Dark Side" of Outsourcing, Outsourcing of Drug Development, October 21-22, 1999 Vienna, Va.
Identifying Chemical Outsourcing Partners and Managing the Relationship over the Life of the Contract, Outsourcing Pharmaceutical Chemistry Services, May 15-16, 2000, Princeton, NJ
John Budzinski, Identifying Chemical Outsourcing Partners and Managing the Relationship over the Life of the Contract, American Pharmaceutical Outsourcing, Sept./Oct. 2000
Managing Strategic Outsourcing Relationships for the 21st Century, PERI Continuing Education Course, December 8-9, 2000, Washington, DC
Managing Strategic Outsourcing Relationships for the 21st Century, PERI Continuing Education Course, December 5-7, 2001, Washington, DC
API Tech Transfer and Support, Development to Commercialization and Beyond
March 18, 2002
Outsourcing Bio/Pharmaceutical Manufacturing, Recognize and Exploit the Value Outsourcing Can Yield, Center for Business Intelligence, June 26, 27, 2003, Boston Mass.
Sourcing of pharmaceutical intermediates and API’s from China and India, SOCMA Purchasing Workshop, Informex Conference, January 19, 2004, Las Vegas, Nevada.
Pharma – The Next Generation, SOCMA Corporate Excellence Conference, Cambridge Maryland, September 14, 2004
Sourcing from China – Two Perspectives,
December, 2004
Weighing the Risk and Benefits of Outsourcing to China and India,
Partnerships with CMO’s, Managing and Improving Outsource Manufacturing
Relationships, April 4-6, 2005, Dallas, Texas
Strategies for Vendor Selection, Risk Management and Trouble Shooting,
IQPCs Contract Management for Pharmaceutical and Biopharmaceutical Company Conference – Workshop Leader (with Gary Conte, V.P. Charkit International)
November 26-29, 2005, San Diego, Ca.
Sourcing Pharmaceutical Materials and Services from China, Web Seminar
Sponsored by Pharmaceutical & Science Group, Advanstar & PharmSource
Presented with Dr. Philip Ma, Global Pharma Sourcing, Feb 12, 2006
Outsourcing R&D Services Session and Panel Discussion Leader, Process R&D Summit
Cambridge Healthtech Institute, Oct. 2-5, 2006, Philadelphia, PA.
John C. Budzinski, Ph.D. 1