Biocompatibility & Toxicology Scientist

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.

About the role

The Research Scientist I of Preclinical (Toxicology and Biocompatibility) supports a portfolio of drug, medical device, drug–device combination, and/or drug packaging system development programs and global registrations. The role applies expertise in toxicology, biocompatibility, and related scientific disciplines to develop and execute nonclinical safety/efficacy strategies, toxicology risk assessments, and/or biocompatibility plans to help assure product (patient) safety and effectiveness. This position contributes to new product development (NPD), sustaining product organization (SPO), and marginal improvement projects (MIP), and supports associated product development lifecycle management (PDLM) processes and initiatives. The role reports to the Associate Director, Preclinical and Toxicology and is part of a global team responsible for drugs and devices supporting Peritoneal Dialysis, Hemodialysis, and Acute Therapies (approximately $5B product portfolio with global reach in more than 100 countries).

Responsibilities

• Author complex study reports and toxicology risk assessments; review and/or concur on toxicology assessment reports as a subject matter expert (SME) in accordance with ICH guidelines and ISO 10993-17.
• Conduct toxicological risk assessments for chemicals used and/or encountered in manufacturing.
• Participate in core technical team meetings as an SME; provide input and lead assigned tasks to support timely project execution.
• Maintain current knowledge of applicable regulatory requirements related to biocompatibility, toxicology, product development, design, and safety.
• Serve as the preclinical/toxicology representative on project teams. Design, plan, and monitor GLP toxicity and biocompatibility studies, and develop risk/safety assessments (including assessment and qualification of impurities, contaminations, leachables, extractables, residual solvents, and excipients) for regulatory submissions.
• Support change control, including impact assessments, and perform and/or support GLP audits and inspections of studies, sites, and facilities (including CROs).
• Prepare and/or review nonclinical eCTD and PBRER sections.
• Use Lhasa Derek and Sarah Nexus software to assess toxicological endpoints.
• Manage assigned project tasks within budget to ensure effective use of financial resources.

Requirements

• Demonstrated knowledge of ISO 10993-1, ISO 10993-17, and ISO 10993-18.
• Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margins of Safety, and Analytical Evaluation Thresholds.
• Strong technical writing and oral presentation skills to communicate study results, safety evaluations, and toxicology assessment conclusions clearly and effectively.
• Ability to work independently and prioritize assignments to meet project timelines.
• Demonstrated ability to collaborate effectively within a global team, including partnering with individuals from diverse scientific and cultural backgrounds across multiple business units and with external partners/CROs.

Qualifications

• Degree in toxicology, pharmacology, chemistry, or a related scientific field, with the following minimum experience in the pharmaceutical and/or medical device industry within GLP/GMP environments:
  • M.S. degree with 8+ years of relevant experience or a Ph.D. with 4+ years of relevant experience.
• Proven experience conducting GLP nonclinical safety (toxicology) studies and performing toxicological risk assessments for extractables and leachables is strongly preferred.
• Experience with safety and biocompatibility evaluations for medical devices and related regulatory guidance (e.g., USP, ISO 10993, EU MDR).

Schedule

This role includes a flexible workplace policy with a minimum of 3 days a week onsite.

Pay

The estimated base salary for this position is $128,000 to $160,000 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Comprehensive health and well-being benefits including medical, dental, and vision coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
• Financial and retirement benefits including the Aon Pooled Employer Plan (Aon PEP) and 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, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.