           
|
|
GMP Manufacturing: Management
At PharmaCore, we understand that our customers are looking for an experienced outsourcing partner to obtain quality results. We have produced dozens of APIs supporting clinical programs around the world. 80% of our projects have resulted in repeat requests in support of expanded trials.
PharmaCore's experienced leadership is an important factor in our success. Our customers trust their future to our experience.
Brian Swierenga, Vice President, GMP Operations
Brian is an experienced chemical engineer with 25 years in the chemical and pharmaceutical industry with particular success in construction and operations management of GMP pilot plants and kilo labs.
Background highlights:
- Director of API Manufacturing at Pfizer, Ann Arbor. Designed and oversaw construction of new 15,000 square foot API manufacturing facility.
- Patent USP 9,940,822,Continuous reactor to produce lithiated trifluorobenzene intermediate to an API
- Director of Operations and Engineering at Parke-Davis leading a large R&D pilot facility and associated engineering groups.
- Lecturer on Chemical Development at University of Michigan's Pharmaceutical Engineering MSE program (2003-2007)
Mark Shapiro, Director, GMP Analytical Chemistry
Mark is an innovative research scientist with a unique and broad 29+ year record of achievement in both the prescription and OTC arenas.
Background highlights:
- Formerly Director, Co-Development Analytical Resources and Global Reference Standards at Pfizer.
- Began career as a pharmacist and moved into QC and R&D chemistry in the generic and Rx fields.
- Expertise in methods development/validation, cleaning validation, PAT and R&D.
- Received the Vice-President's Award for Outstanding Technical Achievement-R&D while at Johnson & Johnson.
- Fifty presentations and publications to his credit.
Michael Johnson, Associate Director of Regulatory Affairs
Mike is an experienced CRO scientist bridging synthetic chemistry background with regulatory oversight in the support of successful API pharmaceutical development. He has extensive regulatory training and experience and has successfully led our GMP projects from the conceptual stage all the way through API production.
Background highlights:
- Formerly research scientist at PharmaCore experienced in process research and development and GMP scale-up up to 200L.
- Patent USP 6,713,580,Quaternary amino acids on solid supports.
- Responsible for implementation of FDA, EPA, OSHA, DOT and DEA regulations.
Bill Smith, Ph.D., Manager, Chemical Development
Bill is a synthetic organic chemist with 19 years of experience in drug development and drug discovery within the pharmaceutical industry. Bill has strong problem solving skills and a broad knowledge of organic synthesis.
Background highlights:
- Formerly a research investigator at GlaxoSmithKline, an organic chemist at Eli Lilly and a senior assistant scientist at Parke-Davis.
- Three patents.
- Expertise in asymmetric synthesis, chromotography and nuclear magnetic resonance spectroscopy.
- Scientific Bronze Awards, GlaxoSmithKline.
- Ten publications in peer-reviewed journals.
