Research Associate E&L (mfd)
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
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 dont 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 youll 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 therapiesas well as business technical and regulatory requirements to meet project needs
What youll bring
Bachelors 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 wed 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
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Required Experience:
IC
Key Skills
- Laboratory Experience
- ELISA
- Immunoassays
- Mammalian Cell Culture
- Biochemistry
- Cell Biology
- Research Experience
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
About Company
The user-friendly Amia APD system, powered by Sharesource Connectivity Platform, is designed to simplify home peritoneal dialysis for both clinicians and patients.
