Stability Chemist III
About the position We currently have an opening for a Research Associate III as Stability Subject Matter Expert. The successful candidate will apply sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics. This role involves the effective integration of chemistry and stability to establish shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert will design strategies and make recommendations that address technical, regulatory, and business requirements. Responsibilities • Represent R&D-Stability on project teams as a key member contributing to project goals and success. • Collaborate with team members including Product Design Owners, Project Managers, Regulatory Affairs, and Quality 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 and defend expiration dating recommendations to key business partners. • Provide input to stability assessments and requirements for new products and current product changes. • Partner with manufacturing facilities, analytical chemistry teams, and stability testing labs to ensure appropriate methods and specifications for stability, compatibility, and release testing. • Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches, providing sound scientific rationale. • Author, review, and verify technical data, protocols, and reports. • Act as study director for stability projects. • Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry. Requirements • 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, methodical approaches to independently solve problems, develop solutions, and make sound recommendations. • 5+ years of experience in Stability testing, R&D lab, Quality control, and Analytical Chemistry R&D. • 7+ years of experience in QC Stability Chemistry including Method Development and Validation, risk assessment, and regulatory standards. • Experience in a regulated environment from Medical Device or Pharmaceutical-FDA (3-5 years). Benefits • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Apply tot his job