New Product Entry Professional

New Product Entry Professional

Category: Manufacturing Location: Gentofte, Capital Region of Denmark, DK
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:

• Preparation of rationales, protocols, and report for Process characterisation and/or Process validation batches.
• Participation in the production of the validation batches.
• Ensuring development of competences within quality and compliance and support in daily quality and compliance decisions for tasks in the team.
• Writing registration documents required for approval of the product for the marked.
• Participation in risk assessment and other workshops to secure high degree of quality in the product and process transfer phase.

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:

• A Master’s degree within natural science, which could be M.Sc. Pharm, M.Sc. In Microbiology or other relevant areas
• Experience in working in a highly regulated environment according to cGMP (good manufacturing practice).
• Proactive and solution-oriented mindset when it comes to solving your tasks.
• Preferably experience in working with new product entry in a production facility and experience from aseptic isolator filling.
• Full professional proficiency in oral and written English and al least an intermediate level of Danish.

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.
Working at Novo Nordisk, BRD Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all Novo Nordisk products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are more than 3400 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support Novo Nordisks initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.
Contact For further information, please contact Associate Manager, Rebecca Rink Disch at +45 30795270
Deadline 19 May 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.