Stability Chemist

Key Responsibilities:

• Represent the R&D–Stability function on project teams as a key member of the project teams' goals and success.
• Collaborate with vital team members (e.g., Product Design Owners, Project Managers, Regulatory Affairs, 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 used to establish expiration dating for product development.
• Supply 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.
• Provide valuable input to stability assessments and requirements for new products and/or current product changes.
• 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.
• Ensure that the methods are appropriate for the product design over shelf life.
• Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
• Author, review and verify technical data, protocols, and reports.
• Act as study director for stability projects under guidance of senior 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. Review data and author technical evaluations that characterize the stability trending of suspect data.
• Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.
• Successfully plan, coordinate, and lead all aspects of the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable.
• Supply to and/or take lead author role for stability sections intended for submission to regulatory authorities. Use computerized systems to retrieve, evaluate, and summarize data for reporting.
• Supply to efforts beyond own scope of responsibilities to ensure project landmarks are met.

Requirements:

• Bachelor's Degree with 5+ years of experience or, Master's with 3+ years, or PhD 1+ years of experience in a relevant scientific subject area.
• Ability to apply logical, methodical approaches in order to independently solve problems, develop solutions, and make sound recommendations.
• Experience working with sophisticated databases.
• Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.
• Good technical writing skills.
• Possess proficiency in analytical chemistry including theoretical knowledge and practical experience.
• Functional understanding of FDA, ISO, and Quality systems.
• Experience Level: Expert Level