Principal Scientist in Clinical Bioanalysis

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Måløv

  • Research
  • Måløv

Would you like to take part in an area that supports the entire portfolio of Novo Nordisk A/S? Are you passionate about bioanalysis? And do you have expert knowledge of industry guidelines? Then you may be the person we are looking for! The department of Clinical Bioanalysis is seeking a highly qualified and motivated scientist to be responsible for bioanalysis in clinical trials.

About the department

The department is responsible for bioanalysis for clinical safety and efficacy evaluations across the entire project portfolio at Novo Nordisk A/S in support of clinical research and/or marketing applications. We develop, validate and use immunoassay bioanalytical methods for quantitative measurement of drugs in samples from clinical trials. We are working in a GLP/GCP regulated environment and we use WatsonLIMS for collection of data and reporting. Our area has a large laboratory facility which houses a range of state-of-the-art techniques e.g. different ligand-binding assays, Gyros and LC/MS and have a strong strategic focus on automating our laboratory and working processes. We also work closely with Contract Research Organisations (CROs) when assays are outsourced.

The department is part of Non-clinical and Clinical Assay Sciences (NCAS) within Global Discovery & Development Sciences and is located in Måløv. The department of Clinical Bioanalysis consists of 9 scientists and 7 laboratory technicians and is primarily using ligand binding assays/immunoassays. We are passionate about our work and appreciate a working environment with good discussions and humour. It is our ambition to support the organisation by delivering good science.

The position

You will join a team in a highly dynamic and challenging environment in Clinical Bioanalysis, where your responsibility will be to provide input to strategy for regulated bioanalysis in new projects, develop immunoassay-based PK assays, validating them in alignment with health authority guidelines, analysing clinical trial samples and ensuring reporting of data. The job also includes transfer and validation of assays from Novo Nordisk to CROs to enable analysis of clinical samples externally where you will be responsible for the outsourced bioanalytical activities.

You will work on several projects/trials in close cooperation with Global Discovery & Development Sciences and Global Development. It will also be part of your role to mentor junior colleagues, provide guidance on interpretation of guidelines, represent Clinical Bioanalysis in cross functional project teams and be responsible for collaboration, providing input to project plans and regulatory documents, as well as timely delivery of bioanalytical data to our stakeholders.

Qualifications

You have a PhD degree within Life Science (e.g. Biology, Biochemistry, Pharmacy, Biotech Engineering etc.) or equivalent pharmaceutical industry experience. You have a minimum of 5-10 years of experience working with development and validation of bioanalytical methods using immunoassays (e.g. ELISA/MSD/AlphaLISA) within the pharmaceutical industry. You have expert knowledge of the regulatory guidelines and the GLP/GCP principles. Experience about clinical trial processes will be an advantage.

As a person, you are flexible, ambitious, have a quality mind-set and a good sense of humour. You work independently, take responsibility, prioritize your own tasks and enjoy handling complex scientific tasks. You are good at communicating written and orally in English and collaborating in a multidisciplinary environment. Furthermore, you have interpersonal skills that allow you to build fruitful relations to both colleagues and stakeholders.

Contact

For further information, please contact Cecilie Freddie Lange at +45 3079 4908.

Deadline

23 August, 2020

Qualified candidates may be called for interview before deadline, so we encourage you to apply as soon as possible.

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 10.7.2020, 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.
  • Forsker
  • Måløv
  • Søndag den 23. august 2020

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