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Senior Stability Scientist

2 months ago

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

We are seeking a highly skilled Senior Stability Scientist to join our team at Actalent. As a key member of our R&D-Stability team, you will play a crucial role in ensuring the stability and quality of our products.

Key Responsibilities
  • Represent R&D-Stability on project teams: Collaborate with cross-functional teams to anticipate business needs and drive project success.
  • Craft and implement stability strategy plans: Develop and execute stability plans for new product development and sustaining projects.
  • Design GMP stability studies: Establish expiration dating for product development and ensure compliance with regulatory requirements.
  • Supply technical justifications: Provide technical support for expiration dating recommendations and defend against regulatory scrutiny.
  • Partner with manufacturing facilities: Ensure the right methods and specifications are available for stability, compatibility, and release testing.
  • Identify risks and opportunities: Provide sound scientific rationale for process improvements and identify areas for optimization.
  • Author and review technical data: Develop and verify technical protocols, reports, and data.
  • Act as study director: Lead stability projects under the guidance of senior Stability team members.
  • Develop new processes: Enhance stability-related practices through process development and optimization.
  • Participate in investigations: Review data and author technical evaluations to characterize stability trending.
  • Lead project coordination: Plan, coordinate, and lead multiple Stability-related projects, budgets, and activities.
  • Supply to regulatory submissions: Author stability sections for submission to regulatory authorities.
Requirements
  • Bachelor's Degree or higher: 5+ years of experience or, Master's with 3+ years, or PhD 1+ years of experience in a relevant scientific subject area.
  • Stability testing experience: Proven experience in stability testing, R&D lab, Quality control, GMP, and Document control.
  • Technical skills: Proficiency in analytical chemistry, computerized systems, and reporting tools.
  • Excellent communication skills: Ability to communicate complex scientific concepts to non-technical stakeholders.