Research Scientist I - E&L

Vantive • Oakdale, MN

2d • $128,000 - $176,000 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum of 10+ years of relevant experience, or MS with a minimum 7+ years of relevant experience or PhD with a minimum 3+ years of relevant experience.
• Hands-on Experience and demonstrated expertise in E&L testing (from wet chemistry sample preparation to Mass spectroscopy using GC and LC methods)
• Study director experience in leading E&L studies, working in cross-functional teams and on-time, on-budget-project execution.
• Performing change control in a GMP environment.

Nice To Haves

• Demonstrated experience in applying risk management methods and tools as part of R&D
• Understanding regulatory expectations and writing cohesive and concise E&L reports for submission to the health authorities
• Being an independent problem solver, who can use a methodical approach to develop solutions, perform root cause analysis, make and implement recommendations.

Responsibilities

• Play a key role in our materials, chemical characterization and E&L team and will bring hands-on and significant technical leadership experience in mass spectroscopy, extractables and leachables for medical device and drug products.
• 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.
• 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.
• Utilize expertise in E&L to perform gap assessments for medical device requirements and support change control activities across the Renal and Acute Care businesses within Vantive.
• Work closely with regulatory, quality, preclinical and product design owning leaders to shape, define and execute product enhancement strategies (for both on-market and new product development) from the perspective of 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.
• Author required reports (internal documentation and regulatory submissions) following pertinent internal and external guidelines and quality procedures that ensures safety and compliance of drugs or devices that Vantive makes.
• 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.
• Stay abreast of emerging sciences and technologies that influence chemical characterization including E&L for medical devices and drugs through active participation in relevant external forums / societies.

Benefits

• medical, dental and vision coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• the Employee Discount Program
• the Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level