Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

We are seeking an experienced Mass Spectroscopist to join our Chemical Characterisation and E&L team. This highly visible role will provide technical leadership in extractables and leachables, mass spectrometry, and chemical characterisation activities supporting both on-market products and new product development initiatives across Vantive's Renal and Acute Care businesses.

The successful candidate will bring deep scientific expertise in E&L assessment, LC-MS and GC-MS analytical techniques, and regulatory compliance for medical devices and/or pharmaceutical products. Working collaboratively with Regulatory Affairs, Quality, Product Development, Materials Science, Toxicology, and Preclinical teams, you will help shape product enhancement strategies, support change control programmes, and ensure continued patient safety and regulatory compliance.

This position combines strategic scientific leadership with hands-on laboratory involvement and offers the opportunity to influence global product portfolios through innovative and risk-based approaches to chemical characterisation.

Duties and Responsibilities:

• Develop and execute Extractables & Leachables (E&L) strategies using risk-based scientific principles within a global regulatory framework.
• Lead E&L assessments and change control activities for medical device and pharmaceutical products across the Renal and Acute Care portfolios.
• Collaborate with multidisciplinary subject matter experts including Materials Science, Toxicology, Biocompatibility, Regulatory Affairs and Product Development to deliver compliant and effective testing strategies.
• Conduct impact assessments, gap assessments and technical evaluations to support product changes, regulatory submissions and lifecycle management activities.
• Serve as Study Director for multiple E&L and chemical characterisation projects, ensuring delivery to quality, timeline and budget expectations.
• Plan and oversee laboratory studies performed internally and through external testing partners, including hands-on experimental work where required.
• Apply advanced knowledge of LC-MS, GC-MS and structure elucidation techniques to investigate chemical species and support product safety assessments.
• Author technical reports, regulatory documentation and scientific justifications in accordance with internal quality systems and applicable regulatory requirements.
• Maintain awareness of evolving scientific, technical and regulatory developments through participation in industry forums, scientific societies and professional networks.
• Partner cross-functionally to understand business priorities, product requirements and regulatory expectations to support successful project execution.

Education and experience:

Required

• Bachelor's degree in a scientific discipline (Analytical Chemistry or Organic Chemistry preferred)
• Demonstrated hands-on expertise in Extractables & Leachables (E&L) testing, including sample preparation, analytical method execution and interpretation of results.
• Strong experience using LC-MS and GC-MS techniques for chemical characterisation and structure elucidation.
• Proven experience leading E&L studies as a Study Director or technical lead.
• Ability to work effectively within cross-functional project teams and manage multiple priorities simultaneously.
• Strong technical writing and scientific communication skills.
• Experience supporting regulated products within the medical device, pharmaceutical or combination product industries.

Preferred

• Experience applying risk management methodologies and tools within R&D environments.
• Knowledge of regulatory expectations related to chemical characterisation and E&L submissions for global health authorities.
• Experience investigating nitrosamines and related impurities.
• Experience supporting change control processes within a GMP-regulated environment.
• Demonstrated problem-solving capability, including root cause analysis and implementation of effective corrective actions.
• Knowledge of ISO 10993-18 and other relevant industry standards for chemical characterisation and biological evaluation.

What Vantive can offer to you:

• A permanent contract with a stable and secure work environment
• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
• A collaborative and dynamic work environment
• Access to state-of-the-art equipment and technology
• Recognition and reward for outstanding performance

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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