Senior Stability Chemist

9 hours ago


Minnesota City, Minnesota, United States Actalent Full time
Job Summary

We are seeking a highly skilled Senior Stability Chemist to join our team at Actalent. As a key member of our R&D - Stability team, you will play a critical role in supporting projects for new and existing products. Your expertise in stability planning and chemistry will enable you to identify and resolve stability indicating characteristics, ensuring the establishment of shelf life for new or existing products.

Key Responsibilities
  • Represent R&D–Stability on project teams, collaborating with key stakeholders to anticipate business needs and gain alignment.
  • Craft and implement stability strategy plans for new product development and sustaining projects.
  • Design GMP stability studies to establish expiration dating for product development.
  • Contribute to the development of technical justifications for expiration dating for new or modified products.
  • Partner with manufacturing facilities, analytical chemistry teams, and stability testing labs to ensure the right methods and specifications are available for stability, compatibility, and release testing.
Requirements
  • 5+ years of experience in Analytical Chemistry R&D.
  • Experience in method development and validation, risk assessment, and regulatory standards.
  • 5+ years of experience in stability experience in R&D.
  • Experience in a regulated environment (Medical Device or Pharmaceutical-FDA, 3-5 years).
  • Global collaboration experience internally (1 year).
What We Offer
  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.


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