Senior Toxicologist (Finance)
Senior Toxicologist
Requisition ID 2025-15921
Posting Date 23 hours ago (1/20/2025 8:05 PM)
Job Location(s) West Lafayette IN United States
Job Locations US-IN-West Lafayette
Position Type Full Time
Company Cook Research Inc.
Category Scientific
Overview
The Senior Toxicologist has responsibility for helping ensure the safety and compliance of medical device products, materials and manufacturing processes for new and existing devices. The person will review, assess, and author/sign documentation supporting safety and compliance, and communicate approaches and outcomes with a broad range of internal and external audiences including technical, executive, regulatory, and others having various understandings of toxicology.
Responsibilities
Collaboratively lead and conduct toxicological assessment of new product design, design changes, manufacturing process and post-production life-cycle activities;
Collaboratively lead and interpret changes to toxicology-related standards (e.g., ISO 10993) and assess impact on existing data and advise on future activities;
Document/sign assessments (e.g., chemical assessments of materials of construction and processing aids in biological evaluation reports (BERs), stand-alone toxicology reports, other) and communicate results;
Provide guidance to senior management on data requirements and toxicological risk control strategies;
Manage multiple toxicological assessments, track projects, and provide status information and updates to stake holders as necessary;
Act as the point of contact for the design and execution of toxicological assessments, including testing, if necessary;
Communicate with CROs and outside vendors, obtain quotes, purchase orders, protocols, and testing reports;
Research and review literature data, regulatory guidance documents, standards, and vendor supplied information;
Collaborate cross-functionally with multi-member teams across departments to clearly communicate with internal and external stakeholders to ensure appropriate planning, and execution of toxicology assessments ;
Provide guidance and mentorship to biocompatibility, toxicology and material team members as needed ;
Act as an interpreter between chemistry information and biological impact, including collaboratively leading, reviewing and interpreting chemical characterization studies (e.g., extractables and leachables) per ISO 10993-18 and FDA guidance, and author/sign toxicological risk assessments per ISO 10993-17 and FDA guidance;
Remain current and apply the understanding of ISO 10993, ISO 14971 and regulatory agency guidance documents (e.g., FDA, PMDA, etc.) and quality system requirements in carrying out duties; and
Conduct other responsibilities when required.
Qualifications
Master 's degree in Toxicology, Biology, Biomedical Engineering, Material Science, or related field required; PhD degree strongly preferred;
DABT and/or ERT certification or eligibility strongly preferred;
Minimum 3 years experience in a regulated industry, preferably in a medical manufacturing environment;
Knowledge of GLP/GMP regulations, medical device materials; metals, plastics, resins and coatings;
Excellent project management skills and able to work on multiple projects simultaneously;
Experience in toxicology requirements of medical devices based on ISO 10993 and FDA guidance;
Experience with in vitro (e.g., chemical, cell culture) and in vivo (animal) test systems;
Able to understand, review and interpret scientific data and regulatory documentation;
Experience writing toxicological risk assessments;
Experience using in silico toxicity models;
Familiarity with analytical chemistry methods preferred (e.g., GC-MS, LC-MS, ICP-MS, and Headspace GC-MS) ;
Excellent scientific documentation writing skills;
Able to effectively communicate ideas to others; and
Able to work independently and in cross-functional interdepartmental teams.
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
