Principal Scientist in Analytical Development for Stem Cell Therapy

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We are seeking a dedicated Principal Scientist with expertise in analytical development for stem cell-based therapy.

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. 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 25 employees, including scientists, project leaders, laboratory technicians and student workers. We have expertise in bioprocess development, stem cell biology and GMP compliance and truly believe that stem cell therapies will make a difference in the lives of patients. If this awakens your interest, please apply and support us in translating stem cell products into the clinics.

The position

We are seeking an experienced and dedicated Principal Scientist to join our analytical method development group, consisting of experienced scientists and laboratory technicians. In the field of cell therapy, products are typically the result of long and complex in vitro differentiation protocols. Therefore, the development of robust product characterization methods is a key success factor for bringing safe cell therapy products to the market.

In this position, you will help develop molecular, cytological and potency assays to demonstrate safety, stability and suitability of pluripotent stem cells banks and their final differentiated derivatives. You will support analytical development, documentation and technical transfers to other production sites. Furthermore, assays to document potency of the cell therapy product need to be developed for use as release analysis for phase III clinical trials. Another important responsibility in this position is to participate in writing regulatory CMC related documents with focus on analyses and characterization input like meeting packages and clinical trial applications for all our projects and to interact with the health authorities round the world. Clinical trial applications are generally written in collaboration with regulatory, other researchers, project managers and clinical trial responsible.

Qualifications

You must hold a PhD degree in Cell Biology, Human Biology, Biotechnology or a similar field of studies. You have more than 5 years of work experience from the industry such as pharma or biotech. We expect you to have a strong scientific background in cell and molecular biology and have documented experience in working with a wide range of analytical methods like ddPCR, NGS, SNP-arrays and flow cytometry for analysing and characterizing cell cultures. Not requested but an advantage is if you have experience with: clinical trial applications like IND’s and CTA’s, developed potency assays for stem cell-based products, CMC experience and finally experience with clinical trials and writing regulatory documentation.

In addition to your strong scientific profile, you are a dedicated and result-oriented team player who enjoys working in an innovative, international and open-minded environment. You can manage multiple projects in parallel and have a sound personal judgement to take decisions during your daily work.

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development.

Contact

For further information, please contact Karsten Nielsen at [email protected] / +45 3075 1286 or Thomas Hassing Ronøe Carlsen at [email protected] / +45 3078 3422.

Deadline

10th February 2020.

Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified.

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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 25.11.2019, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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