Stability Scientist for synthetic manufacturing platforms

The position

We are looking for a Stability Scientist (job seniority depending on the experience of the candidate) 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 task will include the following: Support and maintain overview of the growing portfolio 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 statement Statistical evaluations, data analysis, calculations, and quality statements/rationales Review and approve stability protocol and report for studies conducted at CMOs Be our subject matter expert for API stability in the department Handling urgent issues with the stability with potential impact on product together with product and process responsibles 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. 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 qualification and is 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 Experience within CMC and/or Manufacturing Development (or MSAT) Experience with statistical tools, e.g. JMP and/or SAS for windows Experience with analytical chemistry is an advantage Knowledge of ICH guidelines relevant for API stability 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 assigned to Emerging Technologies API Manufacturing Development (ET API MDev), a cross-functional area currently being established within CMC area. We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management. 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. Please also visit our landing page for more information on our functional area and responsibilities. /careers/career-areas/research-and-development/chemical-development-careers.html 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.