Associate Director Drug Product Manufacturing at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, MA, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 140 ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
The CMC department (Chemistry, Manufacturing and Control) is currently looking for a talented and highly motivated colleague to strengthen the team. The CMC Department develops, manufactures and characterizes oligonucleotides for (pre)clinical development and commercialization.
As our new Associate Director Drug Product Manufacturing, you will be reporting to the Sr. Director Clinical Supplies & Logistics.
What are you going to do:
We are looking for a professional with demonstrated ability to support, develop and drive our late stage drug product manufacturing strategy. The successful candidate will be a highly skilled expert 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 stakeholders (CMOs, distributors etc.).
The Associate Director Drug Product Manufacturing is responsible for all aspects of the supply of ProQR’s oligonucleotide drug products, developed for (ultra)orphan indications. These responsibilities include: 1) supporting global short- and long-term supply strategy, 2) vendor management, 3) operational aspects related to end product supply, and 4) 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, including operational oversight of manufacturing, packaging and labeling activities for specific programs
- Oversee technology transfer, process qualification, scale up and process validation activities at CMO’s
- Provide technical support to manufacturing operations as required
- Support to create, implement and maintain a long-term late stage supply chain strategy
- Execute stakeholder management (CMOs, distributors etc.)
- Manage financial and contractual aspects of assigned projects
- Advanced degree (PhD/MSc/Engineer; or appropriate Master’s level); >8 years of prior experience in managing a global, complex (clinical) supply chain organization in the pharma/biotech industry
- Proven ability to successfully operate a clinical supply chain predominantly based on outsourced capabilities, especially the management of CMOs
- Strong ability to collaborate and build relationships with internal as well as external stakeholders (CMOs, distributors, etc.)
- Successful experience in validation of new drug product processes
- Experience with demand planning and forecasting to improve inventory management while appropriately managing risk
- Ability to take a proactive approach to problem-solving to complete projects according to predetermined timelines and react efficiently to changing priorities
- Well organized and able to multi-task in a fast-paced deadline driven environment
- Prior on-the-ground experience in (contract) manufacturing environment (is highly desirable)
- Development and experience with commercial distribution (is a plus)
- To enjoy challenging situations and have the flexibility to work in a dynamic and fast-moving environment where there is freedom to act
What we offer:
We offer an exciting and innovative working environment, great colleagues, a competitive salary and a lot of fun.
Do you want to be part of our devoted team of enthusiastic professionals? Do you think you can contribute in achieving our mission? Do you want to work in a challenging environment where your work can really make a difference? If so, we’re looking forward to receive your application by filling out our application form.
Please apply as soon as possible, but before December 12th 2018, by filling out our application form.
Please note that an employee screening is part of our selection process.