Stability Scientist

About Vantive

Vantive is a dedicated vital organ therapy company committed to extending patient lifespans and enhancing the care experience worldwide. With a 70-year legacy in kidney care innovation, we focus on improving dialysis through digital and advanced services while also pioneering vital organ therapies. Our mission seeks to provide greater flexibility and efficacy in therapy administration for care providers and improve patient outcomes globally.

Role Overview

The Drug Products and Sciences R&D Stability team supports new and ongoing product development projects. As a Stability Scientist, you will leverage expertise in chemistry and stability planning to identify stability characteristics impacting shelf life and regulatory compliance. You will create stability strategies, manage studies, and deliver scientific recommendations addressing technical and regulatory requirements.

Key Duties and Responsibilities

• Serve as the R&D Stability expert on project teams to ensure achievement of project objectives.
• Design and apply stability strategies for new product development, clinical trials, and ongoing product support.
• Plan GMP stability studies to define expiration dates and support product labeling.
• Develop justifications for expiration dating of new or altered products and defend recommendations with stakeholders.
• Evaluate stability requirements for product launches or modifications.
• Ensure appropriate test methods and specifications are utilized for stability, compatibility, and release testing across shelf life.
• Identify and mitigate risks while recommending process and technology improvements.
• Coordinate with manufacturing sites to gather test and stability data.
• Lead stability studies as study director including data analysis and technical documentation review and creation.
• Oversee multiple complex projects, including budget forecasting and collaboration with global teams and CROs where applicable.
• Manage sample shipments between manufacturing and testing locations.
• Prepare scientifically robust stability sections for regulatory submissions aligned with industry standards.
• Support method transfer, validation, and verification to ensure timely R&D study execution.
• Investigate atypical or out-of-specification stability test results using critical scientific evaluation.
• Provide expert guidance on cGxP and associated regulations, contributing to policy development and interpretation.
• Continuously improve stability processes and train junior team members.
• Manage stability study data via LIMS, including study setup, data creation, review, and updates.

Required Qualifications and Qualities

• A Bachelor’s degree in a scientific field is essential; a Master’s or PhD is preferred.
• Strong organizational skills with high attention to detail.
• Ability to make informed decisions with limited data and resolve routine issues independently.
• Logical and methodical problem-solving approach, generating sound technical recommendations.
• Experience with advanced databases and data management systems.
• Proficient in computer applications including word processing, spreadsheets, statistical analysis, and reporting tools.
• Excellent verbal and technical writing abilities.
• Comprehensive understanding of ICH, CPMP, USP, EP, Asian guidelines, cGxP practices, US and EU stability regulations, ISO standards, and quality systems.
• Strong theoretical and practical knowledge in analytical chemistry.
• Proactive team player willing to support beyond assigned tasks to meet project goals.
• Embraces diversity and works effectively across multiple time zones with inclusivity.

Benefits and Work Environment

• Permanent employment providing job security.
• Competitive benefits including private health insurance, pension scheme, and annual bonuses.
• Dynamic and collaborative team environment.
• Access to modern equipment and technology.
• Recognition programs rewarding exceptional performance.

Additional Information

Reasonable Accommodation: Vantive is committed to accommodating individuals with disabilities during the hiring process and employment. Requests for accommodations can be directed through company protocols.

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