Expert Toxicologist for Impurity Safety Assessment and Risk Management

Expert Toxicologist for Impurity Safety Assessment and Risk ManagementAt Roche, our culture encourages personal expression, open dialogue, and genuine connections. We aim to prevent, stop, and cure diseases, ensuring everyone has access to healthcare.A healthier future drives us to innovate. In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients to tackle some of the world’s toughest unmet healthcare needs.This position is located in TSAC, a department within the Pharmaceutical Sciences function, driving the non-clinical safety assessment of drug candidates.The OpportunityWe are offering an outstanding opportunity for a Senior Toxicologist to serve as the single point of contact for impurities assessments at Roche Basel. You will play a key role in supporting the safety assessment of impurities and extractables/leachables throughout the value chain, with compliance to the most current regulatory guidelines.Your main responsibilities will be:You are the single point of contact for impurity and E&L risk assessments in drug substances and drug productsYou conduct comprehensive risk assessments of genotoxic impurities in line with ICH M7 and related guidanceYou perform toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing componentsYou provide guidance on thresholds of toxicological concern (TTC), supporting product compatibility and safety dossiersYou design and interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studiesYou draft scientifically justified TBLs for impurities, leachables, residual solvents, and raw materialsYou apply appropriate risk assessment methodologies (e.g., AI, PDE, TTC) in accordance with ICH and EMA/FDA guidelinesYou support the integration of TBLs into product specifications and cleaning validation proceduresYou collaborate with cross-functional teams to ensure control strategies are scientifically sound and compliantYou work closely with analytical chemists, formulation scientists, quality assurance, and regulatory affairs along with our Occupational Safety TeamsYour evaluations will be pivotal for the release of new batches from the manufacturing and quality functionsYou represent Roche as KOL in Industry Consortia and regulatory framework discussions groupsYou will advise and support project teams with regard to regulatory requests in the frame of impurities and contribute to internal scientific governance and decision-making forums on impurity and safety issuesWho You AreYou hold a PhD and MSc in Toxicology or a pharmacology/toxicology-related discipline and have broad knowledge in toxicology and chemistryYou have a minimum of 5–10 years of experience in pharmaceutical or biotech toxicology, with strong expertise in impurity assessments and proven experience in E&L toxicological risk assessmentsYou possess working knowledge of genetic toxicology and have robust experience in the area of QSARs, computational toxicology, and the design and application of impurity safety databasesYou have profound knowledge of ICH guidelines (M7, S9, Q3A/B/C/D, etc.), TTC principles, and relevant regulatory frameworksYou have a broad understanding of drug development and manufacturing processes, along with strong analytical skills and a commitment to scientific excellenceYou possess strong communication and interpersonal skills, with experience engaging regulatory agencies (EMA, FDA, etc.)Roches is an Equal Opportunity Employer. #J-18808-Ljbffr