Product Supporter to Biopharm marketed products

Arbejdssted
Gentofte, Denmark
Oprettet
8. februar 2019
Udløber
5. marts 2019
Ref
224482
Are you interested in working with Biopharm's broad portfolio of products for treatment of haemophilia and growth hormone deficiency? Then you may be our new colleague. We are looking for an innovative and skilled professional, who has knowledge within pharmaceutical production and a keen eye for identifying opportunities for improvements.

About the department

In Biopharm, we produce, maintain and improve Novo Nordisk's non-insulin products. You will become a part of the Product Support department in Manufacturing Development. As a department, we are responsible for the specifications of Biopharm's liquid and lyophilised products, and for understanding how the manufacturing process can affect the product quality.

We are approximately 50 engaged and open-minded colleagues organised in 3 teams, and it is our job to support the productions in matters related to product quality and stability. We maintain product specifications and regulatory documents, and we participate in transfer of products from Chemistry, Manufacturing and Control (CMC) to general production in Product Supply (PS) and between facilities.

The job

Your responsibility will be to create and maintain documentation for our marketed products to ensure the required product quality is fulfilled and thereby, securing patient safety. You will write and review documentation defining specifications, stability, master formulars, risk assessments, as well as regulatory submission documents to health authorities. All of this is conducted in cooperation with colleagues in our stability team, quality control (QC), quality assurance (QA), production, and regulatory affairs (RA).

In addition, you will also support both urgent and daily operations in the production by evaluating and concluding on aspects in relation to product quality.

Another important part of the job is to identify opportunities for improvements in daily routines and general processes, where you will either drive the improvement process or support with the required product data and knowledge.

The position is temporary for two years, with the possibility of extension.

Qualifications

You are an experienced engineer, chemist or similar. You have a minimum of two years of experience from the pharmaceutical industry, and hence, you are used to work in accordance with GMP. It is considered an advantage, if you have experience within the regulatory field. Knowledge with stability, aseptic production, compatibility, process validation and/or pharmacopeia requirements is preferable. You are professionally proficient in both written and spoken Danish and English.

As a person, you are responsible, dedicated and have a solid quality mind-set. You are open-minded, committed and are able to motivate your colleagues. You have a positive approach to your job and thrive in a changing environment and with unexpected situations. You will work together with many different people, and therefore, it is important that you are competent at establishing good relationships.

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication, and ambitions help us change lives for the better. In exchange, we offer unique possibilities for professional and scientific development in an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.

We will interview candidates continually, as we receive the applications.

Contact

If you want to know more about the position, please contact Anders Malling Sørensen at +45 3077 6524.

Deadline

4 th of March 2019

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.

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