Analytical Coordinator for Material Manufacturing Development

  • Manufacturing
  • Hillerød

 

Coordinating analytical development and validation activities from clinical phase 3 to launch.

 

Sourcing Operations

Do you want to take part in coordinating the implementation of analytical methods on complex materials and support QC with analytical challenges? And do you have the skills to understand the entire flow of raw materials from selecting the right CMO’s up to final release of the raw materials to production?

 

In that case you should apply for the position as Analytical Coordinator in Material Manufacturing Development (Material ManDev). If you are as ambitious as we are, you can look forward to an exciting job in an environment where we aim to be best in class in everything we do.

 

About the department

You will join Material ManDev department in Product Supply Sourcing Operations that consist of 65 employees organised in five teams. We are responsible for coordinating transfer of complex materials (raw materials, excipients, side chains etc.) from development to production and maintain documentation on existing raw materials. We cooperate with a variety of functions, including CMC development, QC and QA for raw materials, various Novo Nordisk production sites and a range of external contract manufactures (CMO).

 

The job

You will be responsible for coordinating the analytical development and validation activities from clinical phase 3 to launch on materials needed for our new products being transferred from development. A primary focus will be on analytical activities related to complex materials produced at CMO. You will be the CMOs contact regarding coordinating analytical activities to ensure that the CMO has the needed analyses ready to support delivery of the produced material. You will work closely with the drug substance and drug product coordinators across the organisation. You will also have a close cooperation with the chemists in the department to secure timely implementation of new materials and new analytical methods in Novo Nordisk.

 

A broad understanding of analytical methods and validation is needed, and a high cGMP and compliance mind-set is required. In general, the assignments carried out by the department are diverse as we deliver to all parts of Novo Nordisk. This gives a variety of analytical challenges, thus strong collaboration with your colleagues is an essential key to success.

 

Qualifications

You hold a master degree in Chemistry, Pharmacy, Engineering or another relevant fields within the natural sciences. Your degree is supplemented with several years of experience with analytical method validation and in-depth knowledge of working with cGMP in a laboratory environment. Strong project management skills are required. You have a high level of energy to drive yourself and your colleagues forward. You are result-oriented and take pride in delivering on your milestones, and you motivate your colleagues with a positive, forthcoming attitude. You work well independently, although it also motivates you to cooperate with colleagues and stakeholders across functions and departments. Lastly, you must be fluently in written and spoken English.

 

Contact

Associate Manager Martin Skipper +45 30 79 73 64

 

Deadline

26th July 2020. Interviews will be held in August week 32 & 33.

 

Millions rely on us

We are a global healthcare company and life is our reason to exist. This is why we’re all here, to ensure people can lead a life independent of serious chronic disease - millions rely on us. Inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. All those moments that matter. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.


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