Are you motivated by the pulse in a production environment? Do you want to be part of a strong team with high professionalism and challenging processes?
And do you want to be a part of the project implementing and validation of our new Isolator filling line in Biotech and Rare Disease production in Gentofte?
Then you could be the New Product Entry Professional we are looking for. Apply now and join us!
The Position
As a professional in New Product Entry, you will be a part of a highly skilled product transfer team responsible for transferring and implementing new Biotech products in our aseptic filling facilities in Gentofte. The team is involved in the production of products from phase 3 until approval for the marked.
You will support management in project prioritization decisions in quality, compliance, regulatory and validation issues within your responsibility and your responsibilities will include:
All new products will be production in our filling facility which mean according to current GMP requirements for aseptic products.
In the position you will be collaborating closely internally in the department as well as external with other production departments and Manufacturing Development.
Qualifications
To succeed in this role, we expect you to have:
On a personal level, you excel at communication skills, verbally and in writing at all levels, internally from top management to filling operators as well as external consultants and vendors and keep your stakeholders motivated, engaged, and informed. Working in a dynamic environment is something that excites you, with the ability to navigate challenges and see changes as new opportunities. You have a strong collaborative mindset to bring people together to find solutions.
About the department
The Aseptic Production site in Gentofte is part of Biotech & Rare Disease (BRD). At our sites in Gentofte, we are more than 700 colleagues responsible for transforming the API (Active Pharmaceutical Ingredient) into the finished medicine for people living with serious chronic diseases. We work with advanced processes such as formulation, filling, and freeze-drying in a sterile environment. We bring value to our patients by delivering high-quality products in accordance with Good Manufacturing Practice (GMP) in a timely and cost-effective manner, as we continuously optimise our processes and expand with the latest technology.
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