Senior Principal Chemist, Product Stewardship - Toxicology

Overview

The Senior Principal Chemist, Product Stewardship, Toxicology plays a critical role inplays a critical role in ensuring the safety and regulatory compliance of chemical products across global markets. This expert-level position is responsible for designing, overseeing, and interpreting complex mammalian toxicology studies to support chemical evaluations, food contact safety, biocompatibility, and human health risk assessments. The role requires deep knowledge of international toxicological regulations and guidelines, including FD&C, REACH, OECD, and ICH.

Responsibilities

• Expertise on required mammalian toxicology studies for chemical evaluation, food contact, and biocompatibility and human health risk assessments to comply with relevant toxicological regulations (e.g., FD&C, REACH) and guidelines (e.g., OECD, ICH).
• CRO selection and oversight for complex toxicology studies requested for chemical evaluation
• Preparation of regulatory filing dossiers in the US, EU, and Japan (chemical evaluation, food contact, drug master files)
• Assessing impurities levels in the manufacturing process to characterize potential hazards and risks
• Perform toxicology data gap analyses, QSAR analysis, develop read-across assessments and assess potential risks to human or animal health and the environment
• Writing toxicology study waiver requests
• Provide expert scientific advice and guidance to respond to regulatory inquiries in the chemical industry
• Working closely with trade organizations (e.g., ACC) on product and regulatory advocacy
• Personal development to maintain a high level of toxicological expertise and applying that expertise to meet regulatory and safety objectives that align with Celanese’s annual objectives.

Qualifications

• Bachelors degree required. Masters or Ph.D preferred in Toxicology, Pharmacology, Environmental Health Sciences, Chemistry, Chemical Engineering or related discipline.
• DABT (Diplomate of the American Board of Toxicology) or equivalent certification in toxicology or directly related field
• At least 7-10 years of experience in a regulatory environment preferred
• Strong understanding of human health risk assessment concepts and methods, with some familiarity with environmental risk assessment (preferred but not required)
• Demonstrated ability to solve complex scientific and regulatory problems
• Strong interpersonal and collaboration skills in an international working environment.