Over 28 years management, technical and business experience in R&D, Administration
and Manufacturing with recent focus on all aspects of pharmaceutical manufacturing
outsourcing. Strong knowledge of outsourcing processes and vendor capabilities with
many industry contacts. Audited more than 200 suppliers worldwide and more than 50
suppliers in China in the last five years. Broadly networked with other pharmaceutical
professionals to outsource API, finished dosage, quality and packaging.
Ø Pharmaceutical outsourcing
Ø Vendor identification/selection
Ø Contract and price negotiations
Ø Technical transfer and support
Ø Demonstrated costs savings
Ø International experience
Ø Strategic supply chain planning
Ø Cross functional management skills
Ø Facilities management
Ø Organizational development
Ø Sales - bulk active pharmaceuticals
Ø Intellectual property management
Ø Auditing for mfg. suitability
Ø R&D Discovery and Process Dev.
Phelix Pharma Outsourcing Consultants, Inc.
Founder and Principal Consultant (2002 – Present)
Consulting for pharmaceutical and biopharmaceutical companies to find and manage
outsourcing suppliers for their R&D and commercial supply of Active Pharmaceutical
Ingredients (APIs), cGMP intermediates, finished dosage and unique raw materials.
Broad international experience and knowledge of pharmaceutical outsourcing to help
create and manage a capital conserving, highly cost effective, responsive and secure
supply chains for clinical and commercial requirements. Direct management of
outsourcing projects including management of technical transfer. Consultation on
marketing of API and pharmaceutical services to the industry. Staff training and
assistance to increase outsourcing expertise and productivity .
Senior Affiliate Consultant – Seraphim Life Sciences Consulting, LLC
Founder and Managing Director – Global Pharma Sourcing, LLC
DuPont Pharmaceutical Company (now Bristol Myers Squibb)
Senior Director, Strategic Sourcing (1993 to 2002)
- All commercial outsourcing for intermediates and active pharmaceutical ingredients
- Supply chain strategies, capacity planning and long-term support of supply chain
- Contract and vendor relationship management
- Cost control and cost reductions for intermediate and APIs for new and existing
- Vendor management to assure QA and RA compliance with cGMP production
- Vendor selection criteria and vendor strategy to identify key supplier group
- Tech transfer to vendors and ongoing project support at vendors
- Business Manager with P&L responsibilities. - worldwide amorphous warfarin sales
of bulk active and finished dosage to 3rd parties
- Led Manufacturing efforts for API outsourcing for Sustiva™ launch and
- Zero Sustiva™ stock-outs and 70% decrease in costs in 3 years)
- Built and directed strong technical/business team (pharmaceuticals and medical
imaging) to manage all aspects of commercial outsourcing
- Consistently outperformed costs reduction targets for API purchases.
- Broad knowledge of international pharmaceutical outsourcing and vendor
- Assessed over 50 vendor assessment worldwide
- Negotiated key, multimillion-dollar contracts for multiple major products
- Developed many industry contacts for all phases of manufacturing outsourcing.
- Demonstrated ability to work at “R&D – Vendor – Manufacturing” interface to
assure smooth transition and guaranteed supply
- Developed “key outsourcing vendor” network of to support DuPont Pharma
- Partnered with R&D to develop sourcing options and strategies for
candidate/clinilcal development (pharmaceuticals and medical imaging).
Director, Wilmington Area (1990 to 1993)
Facilities management for all DuPont Merck Wilmington sites (1.3 MM sq. ft. of lab and
office space, 100+ reports). Reduced costs by over 25% through consolidation of
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 (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 Human Resources (1988 to
Developed pay and progression systems for DuPont technical professionals. Led
Corporate Committee to define new position evaluation system for DuPont.
Senior Process Research Supervisor, 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.
Postdoctoral Fellow, Arizona State Cancer Research Institute, Arizona State
University (Prof. G.R. Pettit)
Isolation and identification 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 novel
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,
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 C. 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
Outsourcng 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 Informex
Conference, January 19, 2004, Las Vegas, Nevada.
Pharma – The Next Generation, SOCMA Corporate Excellence Conference, Cambridge
Maryland, September 14, 2004
Strategies for Vendor Selection, Risk Management and Trouble Shooting, Contract
Manufacturing Workshop, San Diego, Cal. Nov. 29, 2005 (with Gary Conte – Charkit)
Weighing the Risks and Benefits of Outsourcing to China and India
Patnerships with CMOs, Managing and Improving Outsourced Manufacturing
Relationships, April 4-6, Dallas Texas
|Global Pharma Sourcing, LLC