Research Associate - E&L (m/f/d)

Vantive; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A healthcare technology company in Germany seeks a Research Associate to join their E&L team. The ideal candidate will have a background in scientific disciplines such as Analytical or Organic chemistry with significant experience in E&L testing. Responsibilities include developing strategies for regulatory E&L projects and collaborating with cross-functional teams. Join us to contribute to advancements in vital organ therapies and improve patient care. Competitive compensation and continuous growth opportunities are provided.

Qualifikationen

• Minimum of 7 years of relevant experience for Bachelor's degree holders.
• Knowledge and experience in E&L from wet chemistry to Mass spectroscopy.
• Ability to write cohesive and concise E&L reports.

Aufgaben

• Develop strategies for E&L projects within regulatory frameworks.
• Collaborate with multidisciplinary teams to align E&L strategies.
• Plan and execute laboratory studies related to E&L.

Kenntnisse

Hands-on Experience in E&L testing

Study director experience

Understanding regulatory expectations

Independent problem solving

Fluent in English and good understanding in German

Ausbildung

Bachelor's degree in scientific discipline

MS with a minimum of 5 years of relevant experience

PhD with a minimum of 3 years of relevant experience

Tools

Mass spectroscopy

Wet chemistry sample preparation

GC and LC methods

Jobbeschreibung

Overview

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.

Your role

In this role you will be part of chemical characterization and Extractables & Leachables (E&L) team. This Research Associate role will entail utilization of expertise in E&L and materials to perform gap assessments for medical device requirements and support change control activities across our Renal and Acute Care businesses.

What you\'ll be doing

• Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support extractables & leachables projects and change control activities
• Collaborate with a multidisciplinary team of subject matter experts (e.g. Materials, Biocompatibility, and Toxicology) to develop E&L strategies that align to regulatory requirements for medical devices and drug products
• Plan laboratory work in mass spectroscopy and E&L including independent execution of laboratory studies at in-house or external labs
• Act as study director for multiple studies at any given time and is expected to be able to do wet chemistry and mass spectroscopy (GC, LC, and other appropriate methods)
• Perform E&L change control impact assessments and work with cross functional team members (design owners, materials, preclinical, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to E&L
• Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design, and safety
• Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs

What you\'ll bring

• Bachelor\'s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum of 7 years of relevant experience, or MS with a minimum of 5 years of relevant experience or PhD with a minimum of 3 years of relevant experience
• Hands-on Experience and demonstrated knowledge in E&L testing (from wet chemistry sample preparation to Mass spectroscopy using GC and LC methods)
• Study director experience in leading scientific studies, working in cross-functional teams and on-time, on-budget-project execution
• understanding regulatory expectations and writing cohesive and concise E&L reports for submission to the health authorities
• understanding of polymer chemistry
• performing change control in a GMP environment
• being an independent problem solver who can use a methodical approach to develop solutions, perform root cause analysis, make and implement recommendations.
• Fluent in English and good understanding in German

Have we sparked your interest?

If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we\'d love to talk to you. Apply direct on our Online System.

#IND-DACH

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.