Karen is a highly experienced pharmaceutical consultant with domestic and international expertise in the areas of manufacturing, packaging, logistics, project management and contract negotiation.

Karen’s expertise lies in product outsourcing, manufacturing/packaging transfers, new product introductions, supply chain management and contract negotiations.  She has been a project team leader for product launches and technical transfers for pharmaceutical products marketed globally.

She has been responsible for setting up logistics organizations in manufacturing plants and virtual organizations to ensure compliance and security of supply.

Karen has a B.S. in Packaging Engineering from Michigan State University in East Lansing, Michigan.  In addition, she has a Lean Sigma Green Belt.  Karen lives in West Jefferson, NC USA and has worked on assignments for GlaxoSmithKline in multiple manufacturing facilities including Puerto Rico.

 

Examples of projects completed:

  • Responsible for negotiating, implementing and managing Technical Transfer and Supply Agreements for products being transferred from rationalized manufacturing facilities impacting in excess of 100 global markets. These transfers covered a wide range of dosage forms including solid dose, liquid, ointment, capsule and sterile products.
  • Performed manufacturing, packaging and logistics risk assessments on due diligence teams assessing product acquisitions and in-licensing opportunities.
  • Logistic Director for three manufacturing sites with site responsibilities including distribution, warehousing, planning, import/export forecasting, contract management, customer service and MRP/DRP implementation projects.
  • Logistics project leader for an OTC joint venture which involved multiple manufacturing and distribution sites. This project required labeling changes for over 400 SKU’s, distribution and order entry system integration and QA product release systems.
  • Project leader for raw material changes sourced to contract manufacturers which involved stability testing and regulatory filings in US and global markets.
  • Established the Contract Relations organization for a new Contract Manufacturer that acquired the Burroughs Wellcome facility in Greenville NC. This involved developing project proposals, developing R&D and commercial price structures, hiring and setting up a customer service and order entry department and creating a financial forecasting tool to justify strategic capital spending.