Drug Supply Manager (f/m/d)

Posted on Apr 16, 2019 by Affimed GmbH

Heidelberg, Baden-Württemberg Germany
Health Care
8 Apr 2019
Annual Salary
Full-Time
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
Drug Supply Manager (f/m/d)
(Reference No. OP1901) 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
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.

Reference: 694503885

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