• Job Description

  Req#: 313003

  Do you thrive in an environment with a high variety of tasks and stakeholders? Are you experienced in biocompatibility evaluation and testing of medical devices? If yes, then apply today and be part of our Toxicology Development Projects department, where your expertise will drive innovative solutions in medical device assessment and regulatory compliance!

  The position
  As a Biocompatibility Scientist, you will be part of a skilled team working in a highly dynamic and challenging environment where flexibility, curiosity for new challenges and the ability to prioritize are needed. You will be supporting the organisation within biological evaluation of medical devices and toxicological risk assessment of active pharmaceutical ingredients and impurities. You will base your toxicological safety assessments on literature data, in silico models, chemical analysis and biological testing. All studies are conducted outside our department, either at internal or external laboratories. You will act as sponsor’s monitor and provide scientific input to the studies and test strategies.
  Your main responsibilities will include:

  • Conducting biological evaluation of medical devices and staying updated on evolving regulations and standards in this area to consistently harmonize scientific principles with regulatory requirements
  • Performing toxicological risk assessment of impurities, excipients, extractables and leachables from process equipment and drug primary packaging material and/or being responsible for toxicological assessment and communication of environmental and occupational safety of drug candidates for production facilities
  • Engaging with broad stakeholders, challenging timelines and drawing informed conclusions to drive effective decision-making
  • Being actively involved in improving processes and ways of working

  The job content and level can be adjusted according to your qualifications.

  Qualifications
  You have a master’s degree or PhD in chemistry, biochemistry, chemical engineering or life science combined with strong experience in biocompatibility evaluation of materials and thorough understanding of toxicological risk assessment.
  To be successful in this position we expect you to have:

  • Experience with relevant guidelines and regulations in the medical device area including the ISO 10993 series and MDR regulation
  • Preferably experience with experimental work, either performing it yourself or in collaboration with contract research organizations
  • Ability to undertake many tasks, handle many stakeholders and yet ensure timely delivery. You need to be able to balance high quality with tight deadlines
  • Flair for digital solutions

  On a personal level, you thrive in a dynamic environment with ambitious aspirations. You are proactive and like to take responsibility for new processes and new ways of working.

  About the department
  The department Toxicology Development Projects is part of Global Drug Discovery, Novo Nordisk A/S, located in Måløv. We work closely together with our sister department as a Toxicology Centre of Excellence being responsible for nonclinical safety assessment of drug development candidates. We are responsible for toxicology programs and studies through the clinical development program across the entire Novo Nordisk project portfolio.
  Toxicology Development Projects is a group of 14 people. A self-governing team of 5 people are dedicated to performing biological evaluations of medical devices, occupational and environmental health & safety evaluations of drug candidates and toxicological risk assessment of impurities, excipients, extractables and leachables from process equipment and drug primary packaging material.
  Our area is characterized by an open, sharing, collaborative and ambitious atmosphere with good opportunities for further development.

  Working at Novo Nordisk
  At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 61,000 employees around the world to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.

  Contact
  For further information, please contact Julie Mangor Lovmand, Head of Department on +45 30757879.

  Deadline
  2 September 2024.

  Interviews will happen on an ongoing basis. You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process.
  

  We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

  At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

• About the company

  Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries.

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