Senior Stability Scientist for Synthetic Manufacturing Platforms Expert

2 weeks ago


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

As a Senior Stability Scientist at Novo Nordisk A/S, you will play a pivotal role in driving the successful execution of stability programmes conducted at external contract manufacturing organizations. Your expertise in regulatory requirements for API stability of chemical entities will be crucial in maintaining overview of the growing portfolio of stability studies for chemically synthesized APIs across the synthetic manufacturing platforms.

Your Main Responsibilities
  • Support and maintain overview of the growing portfolio of stability studies for chemically synthesized APIs across the synthetic manufacturing platforms.
  • Design and plan stability studies at external collaborators to document product quality and establishment of retest period/shelf-life.
  • Author internal and external reports and shelf-life statements and handle urgent issues with stability that may impact product.
  • Perform statistical evaluations, data analysis, calculations, and quality statements/rationales.
Qualifications and Skills Required
  • 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.
  • Analytical chemistry experience is an advantage.
  • Proficiency in English.


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