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Arbetsbeskrivning
Clinical Supply Program Lead
Hays Life Science is now looking for a Clinical Supply Program Lead for a consulting assignment at AstraZeneca in Gothenburg. The assignment is initially 1 year with the chance of extension. Send your application no later than July 14th.
About the role:
At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Pharmaceutical Technology and Development (PT&D) is the bridge which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines - from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
Are you a strong project leader? Do you have experience in any of the following areas: supply chain, clinic or pharmaceutical development? If so, this could be the next step in your career!
Our global Clinical Program Supply Chain team is growing, and we are now looking for a Clinical Supply Program Lead to join our team in Gothenburg. Maybe you are the one?
As a Clinical Supply Program Lead (CSPL) you will manage and have responsibility for end to end supply to our clinical studies. These supply chains are complex with typically high variability in demand, long lead times, technical complexity, regulatory constraints and high cost of goods. Our customer expectations are high with a focus on 100% availability of medicine to patients, speed to deliver and at a minimal cost. This complexity is likely to increase, and customer demands will remain high.
The CSPL will lead cross-functional Supply Chain Teams and represent Clinical Manufacturing and Supply on PT&D Project Teams (or similar eg. CMC Teams) throughout the life cycle of the project.
The CSPL works in collaboration with customer functions to influence and manage demand and is responsible for all Clinical Manufacturing and Supply project deliverables to the business through leadership of the Supply Chain Team.
Accountabilities include:
* Collaborating with customers (eg. Global Medicines Development, Global Medical Affairs, and other PT&D and Pharm Sci functions) determine, influence and manage demand for drug substance, drug product and patient packs, including requirements for placebo, comparators and rescue/challenge medication.
* Producing a supply strategy documenting the design, setup and how the supply chain will operate for the project.
* Establishing the Supply Chain for development projects and ensure delivery of the end to end supply of materials, moving from development sources to commercial sources of manufacture.
* Understanding GMP (Good Manufacturing Practice) and the impact it has on supply chain activities.
* Monitoring the performance of the Supply Chain and optimize for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk.
* Accountable for a significant budget for supply activities and materials for a project.
* Maintaining appropriate information for supply activities in PLANIT on an ongoing basis and in line with RBU.
* Ensuring timely delivery of information to meet internal and external regulatory and legal requirements
* Managing change in demand and supply, resolve issues, escalating when appropriate.
Required Skills & Knowledge
* Degree in supply chain related or drug development discipline or equivalent qualification or experience.
* Extensive experience working in supply chains.
* Significant experience managing and influencing customer demands.
* Significant knowledge of drug development, manufacturing, supply chain and clinical processes including GXP standards.
* Experience of project management.