Dynamic qualification scientist for development and implementation of automatization te...

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Are you eager to be part of our voyage towards the break-through formulation, development and production of novel pharmaceutical peptides and proteins? Then this might be just the right career move for you. In our Analytical Support and automatization technology team, we are looking for a qualification expert with a background in analysis and characterisation to support the implementation of analytical automatization technology and secure progress of the automatization of analytical development work in the team.

About the department
As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for non-clinical and clinical trials and represent a strong culture with a “can do” mind-set.

The API Analysis team consists of development chemists and laboratory technicians working closely together on 40 drug projects and automation activities. All automation activities are based on use-cases, and are implemented at pilot scale in a laboratory setting before being more widely implemented.

Currently the team is working with several analytical techniques including HPLC, iCIEF, pH, visual inspection, freezing point depression and CE-SDS, but projects can also include optimizing work processes, data tools or others.

The position

In this position you will be a part of the API Analysis team, where your main responsibilities will be qualification of new technology and managing automatization projects. In particular, we expect that you:

  • Assess feasibility of potential upgrade or replacement of the laboratory equipment to support initiatives such as paperless laboratory, reduction of manual processes through automation and digitalisation of processes.
  • Drive projects and ensure optimal implementation of analytical automatization technology in the team. In other words – we define the projects together, but you’re the qualification expert who see them through.
  • Engage laboratory technicians and relevant experts to ensure implementation and anchoring of equipment qualification projects

You will refer to the team leader of the API Analysis team in department 3533 CMC Analytical development, but the daily work will also include members from several departments across CMC. A lot of stakeholder management is to be expected, as it will be the responsibility in this job to push for implementation of automatization solutions with several stakeholders in Novo Nordisk

Qualifications

You hold a Master’s degree within Life Sciences (Pharmacy, Engineering or other relevant discipline) or equivalent level of experience. You have a sound understanding of drug process development in the pharmaceutical industry, and a proven track-record of contributing to change projects in GMP environments and in validated IT control systems. Ideally, you have gained a thorough understanding of automatization techniques and an extensive understanding of GMP qualification of both equipment and software, including regulatory requirements such as 21 CFR part 11 compliance.

On a personal level you are a team player who also enjoys driving own area of responsibility. You are dedicated towards meeting our common goal and you are not afraid to lead the way for your colleagues and stakeholders. You are eager to see things moving forward in a dynamic environment where projects and processes vary and therefore require you to be flexible and willing to adapt. Additionally, you are a strong communicator and able to communicate complex content to people with different backgrounds and skills, motivating them to hear and follow your ideas and suggestions.

Contact
For further information, please contact Christian Toftegaard Hjuler at +45 3079 0305 or Carsten Schwartz at +45 3075 5628

Deadline
24th of June 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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 12.6.2020, 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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