Senior Stability Scientist for synthetic manufacturing platforms

1 week ago

Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

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Senior Stability Scientist for synthetic manufacturing platforms

Category: Manufacturing

Location:

Høje-Taastrup, Capital Region of Denmark, DK

Are you a skilled stability scientist with good understanding of ICH stability requirements, statistics and/or chemical manufacturing, and want to use your GMP knowledge to support the growth of our synthetic manufacturing platforms? Then you could be our new colleague.

The position
We are looking for a Senior Stability Scientist with good understanding of the regulatory requirements for API stability of chemical entities to drive and ensure the successful execution of stability programmes conducted at external contract manufacturing organizations.

The preferable candidate is experienced in the design and handling of API stability studies as well as the evaluation and trending of stability data for commercial phase products. Knowledge of organic chemistry and/or peptide chemistry is a strong advantage.

Your main tasks will include the following:

  • Support and maintain overview of the growing portfolio of stability studies for chemically synthesized APIs across the synthetic manufacturing platforms.
  • Support the design and planning of stability studies at external collaborators to document product quality and establishment of retest period/shelf-life.
  • Authoring of internal and external reports and shelf-life statements and handling urgent issues with the stability with potential impact on product together with product and process responsible.
  • Statistical evaluations, data analysis, calculations, and quality statements/rationales.
  • Review and approve stability protocols and reports for studies conducted at CMOs.

This job gives you a unique opportunity to work with multiple stakeholders including Late-Stage Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.

Some travel activities can be expected (visit at CMO's). The position does not involve practical work in the laboratory.

Qualifications
To succeed in the role, we expect that you have some of the below qualifications and are eager to learn any remaining required skillset:

  • Ph.D. or M.Sc. in chemistry, chemical engineering, or equivalent
  • Experience with GMP stability for APIs, preferably small molecules and/or peptides along with knowledge of ICH guidelines relevant to API stability.
  • Experience within CMC and/or Manufacturing Development (or MSAT) and experience with statistical tools, e.g. JMP
  • Experience with analytical chemistry is an advantage
  • Proficiency in English.

As a person, you possess a solution-oriented mindset with a strong practical capability to convert theoretical knowledge into practical solutions for technical challenges. Your ability to communicate and collaborate effectively with internal and external stakeholders across different disciplines in both development and production is highly valuable. Your positive attitude enables you to work efficiently, whether as a team player or independently, on complicated tasks, ensuring timely progress.

About the department
As part of Novo Nordisk's Product Supply organization, you will be part of Emerging Technologies API Manufacturing Science and Technology (ET API MSAT). We receive projects from CMC with a focus on process understanding, implementation, optimization, and life cycle management. We are responsible for Ph3 and commercial stability studies.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.
The department is newly established, presenting a unique opportunity to join at the beginning of an exciting journey, while benefiting from the established way of working in Novo Nordisk.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for a change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we're all working to move the needle on patient care.

Contact
For further information, please contact Sr. manager Camilla Christensen, + 45 30 79 17 67 or Area specialist Masood Hosseini +45 34 44 01 98

Deadline
17 March 2025.
Applications are reviewed on an ongoing basis, so please submit your application as soon as possible.
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 process, please refrain from adding a photo to 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 the communities we operate in. Together, we're life changing.

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