Research Scientist I - E&L

About the role

This role involves planning laboratory work in mass spectroscopy and E&L, including independent execution of laboratory studies at in-house or external labs. The candidate will likely act as study director for multiple studies at any given time and is expected to be capable of performing wet chemistry and mass spectroscopy (GC, LC, and other appropriate methods) hands-on as needed.

Responsibilities

• Play a key role in the materials, chemical characterization and E&L team and 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 ensure 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.

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

Qualifications

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

Skills

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

Benefits

Vantive offers comprehensive compensation and benefits packages for eligible roles. 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. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals. 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.

Pay

The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Schedule

Vantive has a flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.