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Senior Stability Scientist
2 months ago
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: Ensure accuracy and compliance with regulatory requirements.
- Lead stability projects: Plan, coordinate, and execute multiple stability-related projects, working with global teams and CROs as applicable.
- Supply stability sections: Author and review stability sections for submission to regulatory authorities.
- Bachelor's Degree with 5+ years of experience or Master's with 3+ years, or PhD with 1+ year of experience in a relevant scientific subject area.
- Ability to apply logical approaches to solve problems, develop solutions, and make sound recommendations.
- Experience working with sophisticated databases and relevant computer and technical skills.
- Good technical writing skills and proficiency in analytical chemistry.
- Functional understanding of FDA, ISO, and Quality systems.