Project Manager R&D

  • Company: AmerisourceBergen
  • Location: Lake Forest, Illinois
  • Posted: November 12, 2016
  • Reference ID: 00001GAS

PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.

The Project manager will participate in and manage both stability and sterility activities in the stability program for PharMEDium's services.

  1. Assist in the design and acceptance of test method validation protocols, preparation and execution of stability testing protocols.
  2. Manage new product evaluations based on current stability data.
  3. Manage the development of compounding processes and standard operating procedures, project tracking, with outcome of adding new services to current offering.
  4. Manage container closure testing and sterility testing of new services.
  5. Support ongoing sterility and chemical testing of current services.
  6. Interact with PharMEDium's Management level personnel, which include Sales and Marketing, Legal, Quality Management, etc.
  7. Interact with outside vendors, and customers.
  8. Manage job related activities with contract laboratories. Review all data and reports for acceptance. Evaluate alternate contract laboratories; including performing audits as needed, for utilization and comparison against current contract laboratories.
  9. Manage activities related to End Preparation Assurance Program which include method transfers, method validations and daily review of results.
  10. Participate in all internal and external audits
  11. Manage complaint sample reporting and investigations
  12. Other duties as assigned.

  1. BS in Chemistry, Biochemistry, Biology, Pharmacy, or related science field.
  2. Five years related experience in Manufacturing, Quality, or Testing in a laboratory setting.
  3. Knowledge of various biological and chemical equipment testing modalities.
  4. Knowledge of sterility tests per USP Endotoxin testing per USP
  5. Experience in an FDA regulated industry.
  6. Ability to work well within a team and with minimal guidance.
  7. Demonstrated strength in problem solving skills.
  8. Strong written and verbal communication skills.

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