Biocompatibility & Toxicology Scientist

Vantive•Plymouth, MN

6d•$128,000 - $160,000•Hybrid

About The Position

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).

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.
M.S. degree with 8+ years of relevant experience or a Ph.D. with 4+ years of relevant experience in toxicology, pharmacology, chemistry, or a related scientific field, with minimum experience in the pharmaceutical and/or medical device industry within GLP/GMP environments.
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).

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.