Associate Director Occupational & Product Quality Toxicology
Jazz Product Quality Toxicology (PQT) is responsible for providing scientifically sound toxicological hazard and risk assessments to support product quality activities related to Jazz products. These activities include ensuring workplace health and safety for employees handling chemicals, addressing safety risks of drug formulations and impurities, and conducting environmental risk assessments for regulatory submissions and marketing approval of new medicines.
The Associate Director OPQT is the primary contact in the Toxicology Department, supporting product quality and occupational and environmental health aspects across the Jazz products portfolio, from research to registration. This role requires extensive collaboration with peers in Toxicology, Technical Operations, Global Quality, Regulatory Affairs, and other stakeholders. The individual should have significant experience in evaluating product quality requests and responding to regulatory inquiries related to product safety and toxicology. They may also represent the Toxicology Department in drug development teams to discuss quality and health risk aspects of medicines. The role reports to the Head of Toxicology.
Job Responsibilities and Requirements
The individual should be a self-starter with excellent management skills, supporting the company's drug discovery and development efforts.Provide strategic and tactical leadership in compliance with corporate policies and global regulations.Advise SMEs and project teams on product quality concerns, including impurity specifications, leachable/extractables, and excipient levels.Assess non-genotoxic and genotoxic impurities/degradants following ICH methodologies.Author occupational health risk assessments for manufacturing, determining PDE/ADE, OEL, MAC, etc.Collaborate on creating material safety data sheets (MSDS) for products.Support formulation characterization based on regulatory data.Conduct environmental risk assessments to support regulatory submissions like NDA, BLA, MAA.Develop SOPs, departmental processes, and templates as needed.Review scientific and strategic aspects of risk assessments before submission.Stay updated with scientific literature and methodologies related to occupational and environmental risk assessment.Ensure compliance with Jazz Standards and US/ex-US guidelines related to product quality and toxicology.Requirements :
Degree in Occupational or Environmental Toxicology, Pharmacology, Biochemistry, or Biology with 5-7 years of industry experience, preferably in pharmaceuticals or consulting. Board certification (DABT, ERT) or eligibility is desirable.Experience with product quality issues, including impurity assessment, contamination management, and derivation of PDE, ADI, etc.Experience with occupational toxicology, including OEL derivation and MSDS contribution.Experience conducting environmental risk assessments for medicinal products.Familiarity with platforms like Lhasa, Leadscope, Meteor, OECD QSAR Toolbox, ToxTree, or willingness to learn.Proficiency in database search strategies.Excellent communication and scientific writing skills.Ability to interact effectively with diverse audiences.Sense of urgency and ability to thrive in a fast-paced environment.Note: For US-based candidates only.
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