Stability Specialist

About Vantive

Vantive is a pioneering company in vital organ therapies dedicated to enhancing and extending patients' lives worldwide. With a 70-year heritage in kidney care innovation, we are expanding our focus by integrating advanced digital tools and services to improve dialysis and other vital organ treatments. Our goal is to provide care teams with greater efficiency and patients with longer, fuller lives.

Role Overview

The Stability Specialist works within the Drug Products and Sciences R&D Stability team, supporting both new and existing product development projects. This role involves applying advanced chemistry and stability knowledge to identify, assess, and resolve stability-related characteristics of products. By integrating chemistry and stability, the role ensures reliable shelf-life determination and product change qualification globally.

Key Responsibilities

• Serve as the stability representative within R&D project teams, contributing to project goals and success.
• Develop and execute stability strategy plans for new product development and ongoing projects.
• Design GMP-compliant stability studies to define product expiration dating.
• Assist in creating technical justifications for expiration dating and support its defense to key stakeholders.
• Provide expert input into stability requirements and assessments for new products or product modifications.
• Guarantee appropriate testing methods and specifications for stability, compatibility, and product release throughout shelf life.
• Identify risks and opportunities in existing methods and propose scientific improvements.
• Collaborate with manufacturing sites to collect relevant testing information.
• Author, review, and verify technical documentation including data, protocols, and reports.
• Function as study director for stability projects, guided by senior colleagues.
• Manage stability study data in LIMS, including creating studies, reviewing data, and entering results.
• Innovate or refine processes to improve stability operations.
• Investigate atypical or out-of-trend results, preparing thorough evaluations and using scientific reasoning to conclude findings.
• Coordinate multiple global stability projects and budgets, including working with CROs.
• Lead or contribute to preparing stability sections for regulatory submissions, utilizing computerized systems for data analysis and reporting.

Qualifications and Experience

• Degree holder (Bachelor’s, Master’s, or PhD) in a scientific discipline relevant to the role.
• Strong organizational skills with meticulous attention to detail.
• Logical and methodical problem-solving skills enabling independent solution development and sound recommendations.
• Experience working with complex databases.
• Proficiency in technical computer skills including word processing, spreadsheets, tables, graphs, databases, and reporting tools.
• Excellent technical writing capabilities.
• Comprehensive knowledge and practical experience in analytical chemistry.
• Willingness to contribute beyond immediate responsibilities to meet project deadlines.
• Understanding of FDA, ISO standards, and Quality systems.
• Prepared to collaborate in cross-time zone teams and foster an inclusive environment.

Employee Benefits

• Permanent employment with a secure and stable work setting.
• Comprehensive benefits such as private healthcare, pension scheme, and annual performance bonuses.
• A vibrant, team-oriented workplace culture.
• Access to the latest technology and equipment.
• Recognition programs rewarding exceptional contributions.

Additional Information

Reasonable Accommodation: Vantive is dedicated to providing accommodations for individuals with disabilities throughout the application and interview stages.

Recruitment Fraud Awareness: Vantive warns against fraudulent recruiters impersonating company personnel and advises candidates to exercise caution to protect personal and financial information.