Clinical Supply Professional for Stem Cell R&D
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Are you a challenge-seeker who are passionate about securing clinical trial supplies? Do you want to help us build and design a seamless and innovative clinical supply chain fit for cryopreserved drug products and novel therapies? Have you worked with phase 1 trials, and advanced therapies before? Then we need you on board, to secure our growing stem cell based clinical trial portfolio.
About the department
The department Stem Cell Process Development is part of Novo Nordisk’s newly established Stem Cell R&D unit, where we develop novel cell replacement therapies for the treatment of serious chronic diseases, together with the rest of Novo Nordisk and with external collaborators. Our department focuses on the development of manufacturing processes and related analysis. We control processes across the entire pluripotent stem cell workflow, starting with cell line derivation and ending with an efficacious and well-characterised product. Diabetes mellitus type 1, Parkinson’s disease and chronic heart failure are only some of the indications we are currently working on. You will join an international and dedicated group of around 35 employees, including scientists, project leaders, technical coordinators, laboratory technicians and student workers. We have expertise in bioprocess and analytical method development, stem cell biology and GMP compliance and truly believe that stem cell therapies will make a difference in the lives of patients suffering from chronic diseases. If this awakens your interest, please apply and support us in progressing our stem cell projects into the clinic.
The position
The position is unique to the area, as we have only recently progressed to clinical trial phase.
We need you to help us ensure that our stem cell based products will successfully reach the clinical trial sites, that the product handling is feasible and well described, and that the process is in control and fit for cryopreserved stem-cell based products, devices and auxiliary materials such as wash and reconstitution buffers needed for product administration.
We will need a profile who understand pharmaceutical development, who can take charge, collaborate across many different cross-functional areas and provide relevant feedback and sparring on how to solve clinical supply hurdles on a diverse project portfolio.
You will be part of the CMC core team, and you will be expected to take full end-to-end responsibility for the clinical supply chain.
We will need your support to set up and design IWRS, provide insights on IMP planning, labelling and packaging aspects for advanced therapies, conduct trial protocol reviews with a sharp focus on clinical supplies and translate science to tangible procedures, where medication errors are minimized.
Qualifications
You must hold a scientific academic degree in Life Sciences (biology, biochemistry, pharmaceutical sciences or other relevant discipline) at master level or above, preferably combined with 3-5 years relevant experience in clinical supplies – preferably from planning to execution of phase 1 trials.
The ideal candidate has experience within the following:
- Strong subject matter expertise in planning, set-up and execution of phase 1 clinical trials from a clinical supply angle (e.g. planning for drug on site(s), labelling, IWRS, pharmacy manual authoring, clinical trial conduct, product handling and documentation)
- Knowledge of the GMP/GCP regulatory framework of advanced therapeutic medicinal products (ATMPs) – or the willingness to learn and use previous knowledge from a biopharmaceutical setting
- Previous experience with project management, working with and selecting vendors/CMOs and working in CMC core team settings
- Problem solver abilities and strong communication skills are a pre-requisite, as well as the willingness to take risks and invent new paths which will get us fast to clinic without compromising on quality or patient safety
Since we are working in an international environment; proficiency in English, both written and spoken, is also a prerequisite.
As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the project teams.
We are aware that we set high expectations; We can on the other hand offer you a job, where variation is the norm and where your job tasks will be broad. More importantly - we have a high level of trust in you and your skillset, you will be given space to grow and make an impact and you will be supported by our fantastic colleagues who are just as passionate as we hope you are.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change patient lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
If you have any questions regarding the position, you may reach out to Tanja Villumsen at +45 3079 3943 or Gabriel Pemberton at + 45 3079 1658.
Deadline
August 1st 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 22.6.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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