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 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 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.Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of 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. 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 higher 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.Contribute 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.Contribute to efforts beyond own scope of responsibilities to ensure project landmarks are met.Essential SkillsStability testing, R&D lab, Quality control, Analytical Chemistry R&D (5+ years)Method Development and Validation, risk assessment, regulatory standards, etc.Stability Experience in R&D (5+ years)Experience in a regulated environment from Medical Device or Pharmaceutical-FDA (3-5 years)Global collaboration internally (1 year)Document controlAdditional Skills & QualificationsBachelor’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 and Quality systems.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.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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