Director of R & D

  • Company: AmerisourceBergen
  • Location: Lake Forest, Illinois
  • Posted: December 08, 2016
  • Reference ID: 00001GPZ
PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.

The Director of R&D is responsible for development, implementation and technical management of the R&D function for all new and existing service offerings.

  1. Direct and ensure scientific validity / chemical integrity of all Admixtures.
  2. Support corporate growth through defining and directing all testing and investigation necessary for future admixtures program expansions and line extensions.
  3. Scientific interface during FDA, BOPs and other Regulatory agency and Internal Audits.
  4. Supplier Management of third party contract laboratories through multi level contracts, expenditure tracking and contract resolution, this includes managing annual supplier audits.
  5. Direct operations for PharMEDium's internal EPA laboratories.
  6. Determine appropriate testing equipment, personnel structure and deployment of resources in support of PharMEDium's laboratory testing approach to maintain compliance with federal and state standards.
  7. Direct the development and implementation of new preparation testing methodologies.
  8. Manage subject expert consultants through contractual agreements, direct oversight of activities and invoice management.
  9. Define and direct policy for the future state of testing.
  10. Support internal EPA labs through method transfers from external contract laboratories and as technical expert for ongoing analysis and investigational support.
  11. Manage department budgets including forecasting, monthly and yearly budget reconciliation, and tax credit compilation.
  12. Support customer complaint investigations through analytical testing and risk analysis of analytical results.
  13. Manage the Preparation Monitoring Program including interfacing with all facilities and internal and external contract laboratories for sample delivery, testing and out of limits investigations.
  14. Manage and Mentor R&D Project Managers and Laboratory personnel.
  15. Train internal sales representatives on the R&D process and key attributes related to service offerings.
  16. Communication directly with customers as needed.
  17. Presentations for GPO and Hospital System visits.

  1. Bachelor's Degree in Science or related field desired.
  2. Minimum 12 years hands-on experience in Quality or R&D.
  3. Strong scientific, analytical and problem solving skills.
  4. Strong judgment with regard to regulatory, product quality and processing impact as it relates to patient safety.
  5. Ability to provide direction and judgment based one business and scientific rational.
  6. Knowledgeable about FDA regulated environment, aseptic drug manufacturing and compounded sterile admixtures.
  7. Outstanding project management skills and attention to detail with regard to process design and implementation.
  8. Ability to work well under pressure, maintaining control under fire.
  9. Strong leadership skills; excellent verbal and written communication skills.
  10. Success working with cross-functional remote teams.

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