Stability Chemist III

1 day ago

Minneapolis, Minnesota, United States Actalent Full time
About the Role

We are seeking a highly skilled Research Associate III to join our Kidney Care R&D - Stability team as a Stability Subject Matter Expert. This is a permanent position that requires a hybrid work arrangement, with some days on-site in NA, Minnesota, and some days remote.

Key Responsibilities
  • Represent R&D-Stability on project teams as a key member of the project teams' goals and success.
  • Craft and implement stability strategy plans for new product development and sustaining projects.
  • Design GMP stability studies used to establish expiration dating for product development.
  • Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.
  • 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.
  • Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches.
  • Author, review, and verify technical data, protocols, and reports.
  • Act as study director for stability projects under guidance of higher Stability team members.
  • Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.
  • Develop new and/or optimize existing processes and procedures to enhance stability related practices.
  • Participate in investigations that correspond to atypical or out-of-specification/out-of-trend test results.
Requirements
  • Strong background in chemistry and stability planning.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Experience with GMP stability studies and technical justifications.
  • Proficiency in LIMS and other relevant software.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

We are committed to diversity, equity, and inclusion and strive to create a culture of care, engagement, and recognition with clear outcomes. We are an equal opportunity employer and welcome applications from diverse candidates.

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