Stability Expert for Chemical Entities

6 days ago

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

We are seeking a highly skilled Senior Scientist to join our team as a Platform Lead for API Stability. In this role, you will be responsible for supporting and maintaining the overview of the growing portfolio of stability studies for chemically synthesized APIs across synthetic manufacturing platforms.

Key Responsibilities:
  • Design and plan stability studies at external collaborators to document product quality and establish retest period/shelf-life.
  • Author internal and external reports and shelf-life statements, handling urgent issues with stability impacting 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.
  • Collaborate with cross-functional teams to ensure smooth execution of stability programs.

This role offers a unique opportunity to work with multiple stakeholders including Late-Stage Development, Analytical Functions, Global Contract Manufacturing, QA, RA, Sourcing, pilot facilities, production facilities, and external partners.

You will have some travel activities, visiting CMOs, but the position does not involve practical work in the laboratory.

About You:
To succeed in this 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 Our 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.

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