Research Scientist II, Extractables & Leachables (E&L)

Vantive • Oakdale, MN

23h • $152,000 - $198,000 • Remote

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. Your Role The Research Scientist II, Extractables & Leachables (E&L) will be part of Vantive's Materials, Chemical Characterization and E&L Team, and will bring hands-on and in-depth technical leadership experience in mass spectroscopy, extractables and leachables for both medical device and drug products. The person in this role will use their 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. The successful candidate will have a strategic mindset and will work closely with regulatory, quality, preclinical and product design, guiding leaders to shape, define and execute product enhancement strategies (for both on-market and new product development) from the perspective of E&L. This role can be based out of either our site in Oakdale, Minnesota or in the United States (Remote, with approximately 10% travel to the Oakdale, MN site, depending on our needs). This role will design strategies for laboratory work in mass spectroscopy and E&L including independent technical leadership of laboratory studies at in-house or external labs. The candidate will also act as the study director for multiple studies at any given time. The individual is expected to be a proven expert in E&L for medical devices and drugs. The successful candidate will 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. The individual contributor will coach, and mentor other global team members working in the space of E&L and/or mass spectroscopy and thus demonstrated experience in technical coaching and mentoring in mass spectroscopy and E&L is required for this role. The candidate is expected to 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.

Requirements

• Bachelor’s Degree in a scientific discipline (Analytical or Organic chemistry preferred) with a minimum of 14 years of relevant experience, or a Master of Science with a minimum of 12 years of relevant experience, or a PhD with a minimum 9 years of relevant experience
• Hands-on Experience and demonstrated expertise in E&L testing
• Study Director experience in leading E&L studies, working in cross-functional teams and executing projects on-time and on-budget
• Direct supervisory or indirect coaching and mentoring of talent in the areas of mass spectroscopy and E&L
• Ability to travel to our Oakdale, Minnesota site up to 10% of the time, if based out of the United States (Remote)

Nice To Haves

• Experience applying risk management methods and tools as part of R&D
• Expertise in regulatory expectations and writing cohesive and concise E&L reports for submission to the health authorities
• Performing change control in a GMP environment
• An independent problem solver who can use a methodical approach to develop solutions, perform root cause analysis, make and implement recommendations
• Experience in leading E&L programs being executed within a global setting and experience coaching/mentoring junior and senior members of scientific community across global locations

Responsibilities

• 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
• Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design, and safety
• Interact and lead discussions across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to align E&L strategies with regulatory, product and marketing strategies for Kidney Care product portfolio

Benefits

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

What This Job Offers

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