Seasoned Pharmaceutical Manufacturing and Supply Chain Executive with Extensive Broad Range Knowledge

AREAS OF EXPERTISE

Supply Chain Management

Pharmaceutical Manufacturing and Packaging

Regulatory Compliance

Start-Up Strategy and Execution

FDA Compliance

Continuous Improvement

Technology Transfer

Solid Dose, Semi-Solid, Parenteral and Drug/Device Manufacturing

Retail Pharmacy Operations

Business Development and Due Diligence

EXPERIENCE

Sanofi – Head, External Manufacturing North America

Pharmaceutical Solutions Group, Inc. – President and Senior Pharmaceutical Consultant

Cephalon, Inc. –Director, Worldwide Manufacturing Operations

Photogen Technologies, Inc. – Vice President, Manufacturing

Schein/Watson Pharmaceuticals – Vice President, Operations and General Manager, Cherry Hill, NJ and Phoenix, AZ Site Operations

SmithKline Beecham Pharmaceuticals/GSK – Director, Manufacturing Supply Chain, Worldwide Supply Operations
– Director, Regional Compounding, Worldwide Supply Operations
– Senior Manager, Anti-Infection Operations
– Manager/Senior Manager, Pharmaceutical Production

Merck & Company – Quality Control Pharmaceutical Production Auditor
– Pharmaceutical Technical Supervisor

Medicine Shoppe Pharmacy – Co-owner and Pharmacist

The Warrington Pharmacy – Co-owner and Pharmacist

ASSOCIATIONS

American Association of Pharmaceutical Scientists

American Pharmacists Association

Parenteral Drug Association

EDUCATION

Ph.D. Pharmacy-Health Policy, University of Science in Philadelphia

MBA, Management, LaSalle University, Philadelphia

BS, Pharmacy, Philadelphia College of Pharmacy and Science

 

 

Kenneth J. Sylvester, Principal

Ken is a pharmaceutical manufacturing and supply chain executive with extensive broad range knowledge. He has a demonstrated outstanding record in managing diverse organizations and achieving tangible results in areas of solid-dose, medical device/drug combinations and parenteral plant operations management. His industry experience includes technology transfer, validation, regulatory compliance, supply chain management, employee empowerment and continuous improvement.

Highlights:

  • Held overall P&L responsibility for $120 million operating budget to support $1 billion in product sales for the North American External Manufacturing operation of a global pharmaceutical company involved in the production of finished product at third-party pharmaceutical manufacturing facilities.
  • Established a consulting company that provided service in operation management, continuous improvement, supply chain management, validation and engineering to the pharmaceutical and medical device industries. Managed a project to deliver a formulation and fill vaccine production facility to support influenza and meningitis products at a major pharmaceutical site.
  • Managed the global commercial supply chain and developed the commercial manufacturing launch plan for a new solid-dose product to treat Attention Deficit and Hyperactivity Disorder (ADHD) for an integrated biopharmaceutical company.
  • Spearheaded a start-up pharmaceutical company’s product development, supply chain sourcing, purchase and distribution initiative from multi-source global contract manufacturers for API and finished product.
  • Directed the overall operation of two major parenteral and solid-dose manufacturing sites and associated support facilities for a vertically integrated generic company that produced penicillin, cephalosporin and general pharmaceutical products.
  • Managed the design, construction, validation and start-up of one of the first U.S. Regional Compounding Center (RCC) facilities supplying compounded products to a major hospital network, which reduced hospital drug cost by 25% using a patented filling process and bulk containers.
  • Holds U.S. patents on method and apparatus for automatically transferring liquids between containers and automatically producing a plurality of sterile liquid filled delivery.
  • Registered Pharmacist in Pennsylvania and Massachusetts.