________________________________________________________________________________________
Due Diligence
Has represented Manufacturing/Supply Chain in more than 30 due diligence projects assessing the acquisition difficulty, cost, and risk of multiple supply chain scenarios.
Contract Negotiations
Successfully negotiated manufacturing aspects of supply agreements with companies such as Takeda, Boehringer Ingelheim, and Daiichi Sankyo. Authored and taught in-licensing/out-licensing course for manufacturing personnel.
Alliance Management
Followed contract negotiation with fine design and operation of the supply chain with partners such as 3M, Pierre Fabre, and Daiichi Sankyo.
Supply Chain Re-Design
Post-launch modifications to supply chains including Daiichi Sankyo Europe (Evista®) and United Therapeutics (tadalafil for PAH).
________________________________________________________________________________________
EXPERIENCE
Launch Leadership
- Global Supply Launch Team Leader for Evista®
- Global Supply Launch Team Leader for Humalog®
- Supply Launch Leader for Humulin® cartridges in the U.S.
- Global Supply Launch Team Leader for Gemzar®
Manufacturing
- Start-up and first Department Head of Humulin Biosynthetic Final Purification, Lilly Building 132
- Department Head of Isolation, Cleavage, and Initial Purification (Humulin®) in Lilly Building 130
- Start-up and first Department Head of Vancomycin Chromatography
- Department Head of Biosynthetic Fermentation
- Department Head of Antibiotic Fermentation and Antibiotic Initial Purification
Quality
- Accepted special assignment as corporate wide Biochemical Validation Task Team Leader following Lilly FDA inspection problems
- Chaired Validation Committee for IQ/OQ/PQ plan for the start-up of Humulin® Building 132
- Team Leader for the cross-functional group that authored the Quality Assurance Lilly Corporate Guideline for Validation
Laboratory/Technical
- Conceived, proved in the laboratory, and validated at full scale the low temperature heat kill of E. coli (as a replacement for the then current inactivation using toluene/phenol)
- Validated the first large-scale (greater than 10L) recombinant DNA fermentor approved for operation by the National Institutes of Health
PATENTS, PUBLICATIONS, CERTIFICATIONS
United States Patent 4,070,247; Stanton C. Burt (sole inventor): Diagnostic Media - Isopropyl-beta-D-thiogalacto-pyranoside as a stimulator of lactose positive reaction in
E. coli diagnostic media.
Co-author of article in the
Journal of Industrial Microbiology titled
"Sterilization of bio-reactor media on the basis of computer calculated thermal input designated as Fo"
APICS Certification in Production and Inventory Management
EDUCATION
Master of Arts - Microbiology
Indiana University • Bloomington, IN
Bachelor of Arts - Biological Sciences
Indiana University • Bloomington, IN