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(Senior) Director Clinical Supplies & Logistics Leiden Netherlands,
Posted on : 16 April 2017
- Our company is a clinical-stage biotech company that is focused on the development of game changing RNA based therapies for severe genetic diseases.
- Our HR department is currently looking for someone that is talented and highly motivated that can strengthen our team. You will report to the Director HR
What we offer!
- We offer an exciting and innovative working environment within a very committed start-up organization, great colleagues and a lot of fun!
- We believe in our strong culture; personal responsibility, flexible workhours and places. Off course we pay a good salary.
- You will have a training budget and we will pay your pension and you will get travel allowance.
- Do you think you can contribute in achieving our mission AND
- Do you want to work in challenging environment where your work can really make a difference?
- We are looking for a (Senior) Director Clinical Supplies & Logistics
What are you going to do:
- The Manufacturing & Pharmaceutics Department is looking for a professional with demonstrated ability to develop and drive our (Clinical) Supply Chain strategy.
- The successful candidate will be a highly skilled professional in the field of drug supply from early development up to commercialization.
- In addition, the successful candidate will be a great communicator with demonstrated success building strategic relationships with internal as well as external (CMOs, distributors etc.) stakeholders.
- The (Sr) Director Clinical Supplies & Logistics is responsible for all aspects of the Supply of company's Oligonucleotide Drug Products, developed for (ultra)orphan indications.
- These responsibilities include:
- global short- and long term supply strategy,
- vendor management,
- operational aspects related to end product supply,
- adherence to GxP requirements related to drug supply.
- Enable delivery of Clinical Drug Products to be tested in clinical trials, meeting Quality and Project Planning requirements.
- Oversee Clinical Supply Chain globally including operational oversight of manufacturing, packaging and labeling activities.
- Oversee technology transfer, process qualification, scale up and process validation activities at CMOs.
- Provide technical support to manufacturing operations as required.
- Drive & maintain company s Clinical Supply Chain.
- Create and implement long term Supply Chain strategy.
- Stakeholder (CMOs, distributors etc.) management.
- Manage all financial and contractual aspects of assigned projects, including vendor negotiations
- Advanced degree (PhD/Engineer; or appropriate Master s level) required.10-15 yrs of prior experience in managing a global, complex (Clinical) Supply Chain organization in Pharma/Biotech Industry. Proficient level of understanding of pharmaceutical business, including drug development process, and legal/compliance global environment.
- Proven ability to successfully operate a Clinical Supply Chain predominantly based on outsourced capabilities, especially the management of CMOs is critical.
- Strong ability to collaborate and build strategic relationships with internal as well as external (CMOs, distributors, etc.) stakeholders.
- Successful experience in launching new drug products globally.
- Experience with demand planning and forecasting to improve inventory management while appropriately managing risk.
- Ability to think strategically and take a proactive approach to problem-solving to complete projects according to predetermined timelines and react efficiently to changing priorities
- Must be well organized and able to multi-task in a fast-paced deadline driven environment
- Prior on-the-ground experience in (contract) manufacturing (managed a manufacturing plant as an example) is highly desirable.
- Ability to build, convincingly communicate and execute strategic and operational plans.
- Should enjoy challenging situations and have the flexibility to work in a dynamic and fast-moving environment where there is freedom to act.
2333 CK Leiden The Netherlands
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