Stability Scientist

About Vantive

Vantive is a company specializing in vital organ therapies, dedicated to extending patient lives and enhancing care options globally. With a 70-year legacy of innovation in kidney care, Vantive focuses on advancing dialysis experiences through digital tools and advanced service models, while actively investing in transformative therapies for vital organs. The company emphasizes delivering greater flexibility and efficiency in treatment administration and aims to improve patient well-being worldwide.

Role Overview

The Drug Products and Sciences R&D Stability team supports new and existing product development projects. The Stability Scientist is responsible for applying advanced chemistry knowledge and stability planning acumen to identify and resolve critical stability-related characteristics in products. By integrating chemistry and stability insights effectively, the role helps define shelf-life parameters for new and existing products aimed at growing markets and supports qualification of product modifications on a global level. This expert position advises on strategies and recommendations to meet technical, regulatory, and business objectives.

Key Duties and Responsibilities

• Act as the R&D Stability representative on project teams to ensure goals and project success.
• Develop and execute stability strategies supporting new product development phases, including clinical trials and sustained operations.
• Design GMP-compliant stability studies to establish expiration dates and assist in accurate product labeling throughout development.
• Provide scientific justification for expiration dating on new or modified products and advocate recommendations to business stakeholders.
• Conduct stability assessments to define needs for new products or modifications to existing products.
• Confirm appropriate use of methods and specifications for stability, compatibility, and release testing aligned with product lifecycle design.
• Identify and evaluate risks, challenges, and potential improvements for existing processes, technologies, and methodologies with scientific rationale.
• Collaborate with manufacturing teams to gather relevant test methods, specifications, and historic stability data when applicable.
• Lead stability study projects as study director, including authoring, reviewing, and validating technical documentation and performing trend analyses.
• Efficiently coordinate multiple complex stability projects, overseeing budgets, and working with global teams and Contract Research Organizations as needed.
• Manage logistics for sample shipments between manufacturing and testing locations, including cooperation with CROs.
• Compose well-founded regulatory submission stability sections in compliance with industry and regulatory standards.
• Partner with stakeholders to ensure timely method transfer, validation, or verification activities facilitating R&D stability studies completion.
• Engage in investigations related to unusual or discrepant test results by analyzing data and providing technically sound evaluations, driving scientific conclusions.
• Maintain expert proficiency in cGxP regulations and guidelines, actively contributing to interpretation and adoption of regulatory standards.
• Innovate or refine processes and procedures to improve stability practices within R&D.
• Coach and mentor junior colleagues in stability-related disciplines.
• Conduct stability study administration using Laboratory Information Management Systems, including study setup, data review, and data management.

Education and Experience Requirements

• Bachelor's degree in a scientific field is required; advanced degrees such as Master's or PhD in a relevant discipline are highly preferred.
• Ability to manage complex information with great attention to detail.
• Demonstrated ability to independently make routine decisions with limited information.
• Logical and methodical problem-solving skills, generating sound recommendations.
• Experience with sophisticated databases and technical computer skills including word processing, spreadsheet usage, statistical analysis, and reporting tools.
• Excellent verbal communication and technical writing expertise.
• Strong knowledge of international guidelines including ICH, CPMP, USP, EP, Asian regulatory guidance, US and EU stability requirements, ISO standards, and quality systems.
• Proficiency in analytical chemistry theory and practical application.
• Willingness to support tasks beyond immediate responsibilities and collaborate across diverse teams globally.

Benefits Provided by Vantive

• Permanent employment contract ensuring stability and security.
• Comprehensive benefits including private medical insurance, company pension scheme, and an annual bonus program.
• A collaborative and energetic working environment.
• Access to cutting-edge equipment and technology.
• Recognition and rewards programs for exceptional performance.

Additional Information

Reasonable Accommodation: Vantive is dedicated to providing reasonable accommodations to applicants with disabilities throughout the hiring process.

Recruitment Fraud Notice: The company warns candidates about fraudulent recruitment scams impersonating Vantive employees or recruiters. Applicants should remain vigilant to protect their personal and financial information.