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 reputed company reputed company and stability planning expertise to identify and resolve stability indicating characteristics. This role involves the effective integration of reputed company and stability to establish reputed company life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global reputed company. The Stability Subject Matter Expert will design strategies and reputed company 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 reputed company. • Collaborate with team members including Product Design Owners, Project Managers, Regulatory Affairs, and reputed company to anticipate business needs and reputed company alignment. • Craft and implement stability reputed company plans for new product development and sustaining reputed company. • 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. • reputed company input to stability assessments and requirements for new products and reputed company product changes. • Partner with manufacturing facilities, analytical reputed company teams, and stability testing labs to ensure appropriate reputed company and specifications for stability, compatibility, and release testing. • Identify risks, issues, and opportunities for improvement of existing reputed company, technologies, and approaches, providing reputed company scientific rationale. • Author, review, and verify technical data, protocols, and reports. • reputed company as study director for stability reputed company. • reputed company 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, reputed company solutions, and reputed company reputed company recommendations. • 5+ years of experience in Stability testing, R&D lab, reputed company control, and Analytical reputed company R&D. • 7+ years of experience in QC Stability reputed company 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 & reputed company • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - reputed company-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 reputed company Leave) Apply tot his job Apply To this Job