Drug Supply Manager (f/m/d)

Reference No. OP1901

Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Operations Team in Heidelberg, Germany, we are looking for a

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Responsibilities

  • Full responsibility and oversight for labeling, packaging and shipment of clinical drug supplies to depots and clinical trial sites, including the controlled transport of drug substance and drug product amongst different manufacturing and service vendors
  • Primary point of contact for inventory control and distribution activities, including planning and scheduling of shipments, issue resolution, change implementation and appropriate documentation related to clinical supply
  • Responsibility for developing forecasts of all drug supply needs in close collaboration with all associated functions
  • Strong collaboration with members from different departments, including Manufacturing, Clinical Operations, Medical, Quality Unit and Regulatory Affairs as well as cross-functional program teams on all aspects of clinical trial supply
  • Ensuring clinical drug supply within timelines, budget, quality and regulatory guidelines
  • Manage third party vendors to ensure appropriate production planning and distribution
  • Ensure timely provision of budget proposals by vendors for requested services, reviews and negotiate proposals
  • Oversee vendor activities, including labeling, packaging, on-time delivery, quality, and issue resolution
  • Generate and review processes / templates and ensure compliance to relevant guidelines and SOPs
  • Develop pharmacy manual in conjunction with relevant function leads and trial teams.
  • Develop drug supply training materials for CRO and trial sites

Requirements

  • Graduate degree (i.e. bachelor, master) in life sciences or medical area
  • Minimum five years of experience in drug supply management in a clinical research environment, with the responsibility for the end-to-end clinical drug supply process
  • Experience in managing cold-chain distribution processes
  • Experience in establishing and maintaining successful relationships with vendors
  • Strong team player and collaborative mindset
  • Good communication skills
  • Proficient user of MS Office applications
  • Background in Clinical Trial Management desirable
  • Prior experience in biopharmaceutical technical development and/or manufacturing desirable
  • Fluent in English (oral & written), German language skills desirable

Opportunity

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team. For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

March 2019

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