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Vantive · 10 hours ago

Research Associate III - Stability SME

St Paul, MN

Full-time

Hybrid

Mid, Senior Level

$96K/yr - $120K/yr

3+ years exp

Vantive is a vital organ therapy company dedicated to improving kidney care and expanding possibilities for patients. The Research Associate III, Stability Subject Matter Expert, will support R&D projects by applying chemistry and stability planning expertise to establish shelf life for products and ensure compliance with regulatory requirements.

Health CareMedicalTherapeuticsWellness

Responsibilities

Represent R&D–Stability on project teams as a key member of the project teams’ goals and success

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 recommendation to key business partners

Provide valuable input to stability assessments and requirements for new products and/or current product changes

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

Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale

Interact with manufacturing facilities to acquire information related to test methods and specifications

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

Optimally plan, coordinate, and oversee 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, summarize data for reporting

Qualification

Analytical ChemistryStability Studies DesignTechnical WritingFDA RegulationsGMP ComplianceDatabase ManagementAttention to DetailProblem SolvingTeam Collaboration

Required

Bachelor's Degree with 5-7 years, Master's with 3-5 years, or PhD with 0-3 years' experience in a relevant scientific subject area

Ability to organize complex information and demonstrated attention to detail

Apply a logical, methodical approach in independently solving problems, developing solutions, and making 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

Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met

Functional understanding of FDA, ISO, and Quality systems

Willingness to work in a team environment across multiple time zones and demonstrates an inclusive attitude