Mass Spectroscopist

About Vantive

Vantive is a pioneering company focused on vital organ therapies, dedicated to improving the lives of patients and healthcare providers. With a 70-year legacy in kidney care innovation, Vantive advances dialysis experiences by integrating digital tools and advanced services while expanding into new vital organ therapeutic areas. Their mission centers on providing greater treatment flexibility, efficiency for care teams, and enhancing patient lifespans and quality of life.

Role Overview

We are looking for a seasoned Mass Spectroscopist to join our Chemical Characterisation and Extractables & Leachables (E&L) team. This leadership role involves guiding scientific efforts in E&L evaluations, mass spectrometry analysis, and chemical characterization for existing and new products within our Renal and Acute Care divisions.

Key Responsibilities

• Create and implement scientific, risk-based E&L strategies that comply with global regulatory standards.
• Lead E&L evaluations and manage change control processes for medical devices and pharmaceutical products in our portfolios.
• Collaborate with experts in Materials Science, Toxicology, Biocompatibility, Regulatory Affairs, and Product Development to develop compliant testing methodologies.
• Perform impact and gap analyses, technical assessments to support product modifications, regulatory filings, and lifecycle management.
• Act as Study Director for numerous E&L and chemical characterization projects, ensuring alignment with quality, schedule, and budget objectives.
• Coordinate laboratory investigations internally and with external partners, actively engaging in experimental work as needed.
• Utilize advanced LC-MS, GC-MS, and structural elucidation methods to analyze chemical compounds and contribute to safety evaluations.
• Produce technical reports, scientific documentation, and regulatory submissions adhering to internal and external quality and regulatory criteria.
• Stay informed of scientific, technical, and regulatory changes via industry participation and professional networks.
• Work cross-functionally to align scientific activities with business goals, product requirements, and compliance needs.

Qualifications and Experience

Essential:

• Bachelor’s degree in a scientific field such as Analytical or Organic Chemistry.
• Substantial practical experience in Extractables & Leachables testing, including sample prep, method execution, and data interpretation.
• Proficiency with LC-MS and GC-MS techniques for chemical profiling and structural analysis.
• Track record of leading E&L studies as a Study Director or technical lead.
• Ability to manage multiple priorities and collaborate effectively within interdisciplinary teams.
• Strong technical writing and communication skills.
• Experience supporting medical device, pharmaceutical, or combination product regulatory environments.

Preferred:

• Familiarity with risk management tools and methodologies in R&D contexts.
• Knowledge of global regulatory requirements for chemical characterization and E&L submissions.
• Experience investigating nitrosamines and related impurities.
• Exposure to change control processes in GMP-regulated settings.
• Problem-solving abilities including root cause analysis and remedial action implementation.
• Understanding of ISO 10993-18 and associated chemical and biological evaluation standards.

What We Offer

• Permanent employment with job security in a stable work environment.
• Comprehensive benefits including private medical insurance, company pension plan, and annual bonuses.
• A collaborative and dynamic workplace culture.
• Access to cutting-edge laboratory equipment and technology.
• Recognition programs rewarding exceptional performance.

Additional Information

Vantive is committed to providing reasonable accommodations to applicants with disabilities during the hiring process upon request.

Warning: Be cautious of fraudulent recruitment activities impersonating Vantive employees or agents aiming to steal personal or financial information.