Robert H. Fennel, PhD
Robert H. Fennel, Ph.D. Sr. Quality Scientist/Operations and Product Development
Bob has 25 years of diverse management experience in the medical diagnostic and device industry. His expertise includes operations management, process design, reagent manufacturing, quality assurance, regulatory compliance, continuous improvement, facilities management and training. He is motivating team builder with a proven track record in project management, problem-solving, cost control, validation and quality system compliance.
Robert has bee responsible for the rapid transition of new products into the manufacturing operations and re-engineering for cost and quality improvements. This included direction of a multifunctional organization of more than 130 people responsible for the manufacture of all diagnostic reagents, controls and calibrators supporting hematology, clinical chemistry and immunoassay analyzers worldwide.
EXPERIENCE:
- Wrote and trained the corporate procedure for preparing training modules for a major medical device company. Led a team for a microbiology training program for a device manufacturer in Mexico.
- Served as Co-Team Leader for Design Validation for a major diagnostic company. The result of this team effort was the successful restoration of compliance with the FDA Quality System Regulations.
- While at Syva, Bob chaired the CAPA Committee resulting in a dramatic improvement in closures times and long-term effectiveness of preventative actions.
- As Director of Operations’ Engineering led a multifunctional team to consolidate the Development, Marketing, Finance and General Administration functions into a reduced floor plan to save $4 million in annual occupancy charges.
- Designed and implemented a simplified and logical document management system.
- Started and directed a plant-wide, lean manufacturing (Kaizen) program netting a >50% reduction in production cycle-times.
- Directed a project to upgrade the state of validation for a reagent manufacturing plant.
- Directed the consolidation of the Packaging function into the central production facility saving $1MM in annual lease cost.
- Instituted a new process for the manufacture of calibrators with enhancements to product consistency and cost improvement.
- Directed the cross-country relocation of two acquired companies.
- Introduced new test methods and specifications incorporating medical utility frequency as the statistical basis for the release criteria.
- Directed the re-design of manufacturing operations utilizing value chain process mapping.
- Managed the commercialization of the Technicon Immuno-1 analyzer from research through product launch as a member of the Core Product Delivery Team.
- Directed the building of facilities and installed manufacturing systems and procedures for the reagents, calibrators and controls supporting the Immuno-1 analyzer.
- As Director of Manufacturing directed the multifunctional organization of >130 people responsible for the manufacture of all diagnostic reagents, controls and calibrators supporting hematology, clinical chemistry and immunoassay analyzers worldwide.
- Directed the licensing and manufacturing of a veterinary vaccine with the U.S.D.A. and Limulus Amoebocyte Lysate with the F.D.A.
POSITIONS HELD:
Director of Operations Rorer Pharmaceutical
Director of Manufacturing Bayer Diagnostics
Director of Operations’ Engineering Syva Company
Project Manager Bayer Diagnostics, Dade Behring
Senior Quality Engineering Consultant BioQuest Corporation, Accureg,
EDUCATION:
Ph.D., Microbiology, University of Pittsburgh, School of Medicine
M.S., Microbiology, University of Pittsburgh, School of Medicine
B.S., Chemistry, University of Pittsburgh, Pittsburgh, Pennsylvania
Continuing education courses in operations management, finance, project management and problem-solving
