Job Description
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. 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.
ResponsibilitiesRepresent 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 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 optimize existing processes and procedures to enhance stability-related practices.Participate in investigations related to atypical or out-of-specification/out-of-trend test results, review data, and author technical evaluations characterizing the stability trending of suspect data.Leverage critical thinking to drive investigations to conclusions based on sound scientific principles.Plan, coordinate, and lead all aspects of multiple Stability related projects, budgets, and activities 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 milestones are met.Essential Skills5+ 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).Global collaboration experience (1 year).Document control experience.Additional Skills & QualificationsBachelor’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.Experience working with sophisticated databases.Proficiency in 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.Work Environment
Flexible workplace policy which includes a minimum of 3 days a week onsite. This is a desk-based role and an individual contributor position with no lab work involved.
Pay and BenefitsThe pay range for this position is $114000.00 - $114000.00
• 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)
Workplace Type
This is a hybrid position in Minneapolis,MN.
Application Deadline
This position will be accepting applications until Dec 27, 2024.
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.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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