Y-mAbs Therapeutics A/S
Clinical and Commercial Supply
As Supply Chain Manager, you will have the overall responsibility to secure timely supply for the clinical trials and the upcoming commercial requirements in the launch of the two products, naxitamab (naked antibody) and omburtamab (radiolabelled) to markets worldwide). The manufacturing & supply chain for especially omburtamab is very complex due to the radiolabelling, and therefore set high demands for professional and seamless processes and operations.
The job involves every aspect of the supply chain, to secure a seamless technical transfer from development to product supply to secure successful launches in a sustainable and steady commercial supply chain.
Entrepreneurial Phase = Hands on!
As this is a small company in an entrepreneurial phase, the role will both include process development as well as the quite operational tasks in the implementation and operation of the manufacturing & supply activities. All manufacturing activities are outsourced, and a big part of your job is to develop and run a close and steady collaboration with CMOs, 3PLs and other supply chain-partners to secure timely and accurate supply. You will furthermore work closely together with your colleagues in CMC, commercial operations, clinical operations and medical affairs.
Specific work tasks:
- Generation and revision of Work Orders with secondary packaging company for clinical and commercial supply.
- Review and approval of master packaging records together with RA
- Overview of time lines for manufactured batches for Drug Substance (DS), Drug Product (DP) and Investigational Medicinal Products (IMP)
- DS and DP supply forecast for clinical and commercial supply
- Oversight of expiry dates and needs for shelf-life extension
- IMP and commercial product inventory maintenance
- Participation of mock recalls
- Handling of IMP orders from clinical Investigator’s sites and contacts with the sites regarding IMP supply
- IMP returns/destruction handling
- Label approval
Clinical and commercial supply processes and operations.
We expect you to have 5-10 years of experience from similar positions in global pharmaceutical manufacturing & supply chain roles. Furthermore, you have experience with working in outsourced manufacturing environments and collaboration with CMOs etc. and a proven track record in supporting the technology transfer from late stage development through launch to commercialization. Finally, English proficiency at a professional level, both written and spoken are prerequisites.
You are a true team player and have the ability to work in a cross-functional team in a fast-paced environment with ambitious timelines. You have an entrepreneurial mind-set, are result-oriented and committed to contribute to the overall success of Y-mAbs.
Unique opportunity – Make a difference
This role offers a fantastic opportunity to be a key player in bringing these innovative treatments out to the benefit of the patients. Patients suffering from severe conditions. You will be involved in every aspect of the supply chain, and really be able to make a true and visible difference. Join Y-mAbs on this exciting journey!
Interested? Don’t hesitate.
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. Please submit your CV and application in English on www.compasshrg.com – If you would like to find out more about this position before submitting your application, please do not hesitate to contact Senior Research Consultant Joan Hemmingsen from Compass on tel.: +45 70 20 12 75. Please note that we will reply to the email address from which you send your CV.
Y-mAbs Therapeutics A/S is a Danish affiliate of Y-mAbs Therapeutics Inc., which is located in New York. Our mission is to discover, develop and deliver novel antibody therapeutics for the treatment of both pediatric and adult cancer patients. Working at Y-mAbs, is therefore a unique chance to be part of an innovative Danish biotech company with global impact! Y-mAbs is a true entrepreneurship, where you will get the chance to make a huge difference in bringing these innovative treatments out to the benefit of the patients. See more at www.ymabs.com
Deadline for application: As soon as possible
Company: Y-mAbs Therapeutics A/S