Job Title: Stability Chemist III

Job Description

The Kidney Care R&D - Stability team supports R&D projects for new and existing products. We currently have an opening for a Research Associate III to represent Kidney Care Solutions as a Stability Subject Matter Expert. The successful candidate will apply sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics. The effective integration of chemistry and stability enables the establishment of 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 designs strategies and makes recommendations that are non-routine to address technical, regulatory, and business requirements.

ResponsibilitiesRepresent R&D–Stability on project teams as a key member contributing to the project teams' goals and success.Collaborate with vital team members such as 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 used 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 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.Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches and provide sound scientific rationale.Author, review, and verify technical data, protocols, and reports.Act as study director for stability projects under the guidance of 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 investigations 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.Contribute to and/or take a lead author role for stability sections intended for submission to regulatory authorities.Use computerized systems to retrieve, evaluate, and summarize data for reporting.Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.Essential Skills5+ years of experience in Stability testing, R&D lab, Quality control, and Analytical Chemistry R&D.Experience in Method Development and Validation, risk assessment, and regulatory standards.5+ years of Stability Experience in R&D.3-5 years of experience in a regulated environment from Medical Device or Pharmaceutical industries.1 year of experience in Global collaboration internally.Bachelor’s Degree with 5+ years of experience, or Master’s with 3+ years, or PhD with 1+ years of experience in a relevant scientific subject area.Ability to apply logical, methodical approaches to independently solve problems, develop solutions, and make sound recommendations.Experience working with sophisticated databases.Relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.Good technical writing skills.Proficiency in analytical chemistry including theoretical knowledge and practical experience.Functional understanding of FDA and Quality systems.Additional Skills & QualificationsExperience in document control.Proficiency in analytical chemistry including theoretical knowledge and practical experience.Work Environment

Flexible workplace policy which includes a minimum of 3 days a week onsite. This is a desk-based role, and the individual will not be working in the lab at al

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