Analytical scientist with regulatory experience to Biopharm Analytical Manufacturing De...
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Gentofte
- Manufacturing
- Gentofte
Are you our new colleague in the New Product Support (NPS) team in Novo Nordisk in Gentofte?
Do you want to be part of a dynamic department that holds the responsibility of writing regulatory submission documents related to analytical methods, transfer of analytical methods to affiliates and method validation of Biopharm’s portfolio of haemophilia products? Then this position will suit you.
The department
In Biopharm Analytical MDev we validate and optimise analytical methods for new products within e.g. haemophilia and growth hormone. Furthermore, we write the associated documents to authorities worldwide and support the QC laboratories in Biopharm on tasks that create more productivity.
We are 43 employees in the department, organized in three teams and a staff function that takes care of activities across the department. In the department we have a good and informal atmosphere, a good work-life balance and we share knowledge across teams and professions.
The position
You will be part of a team responsible for preparation of analytical documentation to the authorities as well as protocols and reports documenting transfer of the analytical methods to our affiliates according to current regulatory requirements. When possible, we assist our colleagues in the two validation teams with tasks within analytical method validation.
Your will spend most of your time writing regulatory documentation which covers the analytical part of Module 3 in our development projects and answering related questions from authorities around the world.
You will have contact with many colleagues outside the team and will be in close dialogue with the development departments, Biopharm QC and Quality Assurance (QA). All in all, it is a challenging and stimulating job that requires energy, drive and flexibility.
The position is a temporary 2 years assignment.
Qualifications
- You hold a Master’s degree in Science within Pharmacy, Chemistry or a similar field
- You have experience from a job where you have either assessed or have been writing analytical regulatory documents
- You are fond of writing and you are good at creating an overview and prioritizing your tasks; even when deadline approaches
- You thrive in a busy environment with an unpredictable work day where you are faced with challenging issues and on the other hand must adjust small details
- You never compromise on quality and at the same time you are good at completing your tasks in time and move on to new tasks with energy and enthusiasm
- You are a team player – openminded, engaged and able to inspire and motivate your colleagues. We expect you to possess good communication skills in both oral and written English and Danish
Working at Novo Nordisk
At Novo Nordisk your skills, dedication and ambition help us change lives for the better. In exchange we offer you to work with extraordinary talent and give you the opportunity to get an insight into a complex business area where culture, politics, a broad product range and various manufacturing sites are part of the daily business.
Contact
For further information, please call associated manager Ann Mürer on +45 3075 7796
Deadline: 8. september 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.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 15.8.2019, 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
- Gentofte
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