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Associate Director, Occupational & Product Quality Toxicology

Company: Disability Solutions
Location: Sacramento
Posted on: July 3, 2024

Job Description:

Associate Director Occupational & Product Quality ToxicologyJazz Product Quality Toxicology (PQT) is primarily responsible for providing robust, scientifically sound toxicological hazard and risk assessments to support product quality activities associated with the manufacturing and marketing of Jazz products. These activities include health and safety of the workplace for employees handling proprietary and non-proprietary chemicals used in the production of Jazz products; addressing potential safety risks associated with drug formulations excipients and with drug substances and drug products impurities; and for conducting environmental risk assessments to support regulatory submissions and marketing approval of new medicines.The Associate Director OPQT is the primary point-of-contact in the Toxicology Department with accountability for supporting product quality and occupational and environmental health aspects in regard to Jazz products portfolio, from research to registration and beyond. This is a highly interactive role requiring extensive collaboration with peers in the Toxicology Department, Technical Operations, Global Quality, Regulatory Affairs, and other stakeholders. This individual has significant experience in evaluating and responding to product quality requests (e.g., potential health risks of excipients, degradants, and/or impurities) and to occupational and environmental toxicology inquiries from global regulatory authorities in support of major submissions and commercial batch release. The individual may be requested to represent the Toxicology Department at drug development project teams to convey aspects pertaining to the quality, occupational and/or environmental health risks of experimental and/or marketed medicines. The Associate Director OPQT reports to the Head of Toxicology.Job Responsibilities and Requirements

  • The individual is a self-starter with excellent management capabilities and is a critical part of an innovative team that supports the company's drug discovery/development effort.
    • Displays tactical and strategic leadership in compliance with corporate policies and standards and global regulatory requirements.
    • Advises Toxicology SMEs and/or project teams on product quality-related concerns (e.g., specifications for known impurities and degradants, evaluation of leachable/extractables, and acceptability of excipient levels).
    • Assess non-genotoxic and genotoxic impurities/degradants per ICH methodologies.
    • Authors occupational health risk assessments for small and large molecule manufacturing (e.g., determination of permissible/acceptable daily exposure (PDE/ADE), occupational exposure limit (OEL), maximum allowable carryover (MAC) values, etc.).
    • Co-authors material safety data sheets (MSDS) for Jazz commercial products in collaboration with Technical Operations or other stakeholders.
    • Supports the characterization and acceptability of formulations excipients based on available regulatory information.
    • Oversees/conducts environmental risk assessments to support NDA/BLA/MAA.
    • Develops standard operating procedures (SOP), departmental processes and templates, as needed.
    • Reviews scientific and strategic aspects of occupational/risk assessments prepared by others prior to finalization and regulatory submission.
    • Addresses other relevant issues on an ad hoc basis.
    • Maintains a current understanding of the relevant scientific literature and methodologies related to the specific aspects of occupational and environmental risk assessment.
    • Responsible for upholding Jazz Standards related to Product Quality/Occupational toxicology in compliance with US and ex-US guidelines. Requirements:
      • M.Sc. or Ph.D. in Occupational or Environmental Toxicology, Pharmacology, Biochemistry or Biology with 5-7 years of industry experience, preferably in a pharmaceutical or consultancy setting. Board certification in Toxicology (e.g., DABT, ERT) or eligibility to write the exam desirable.
      • Broad experience with Product Quality issues, including assessment of non-genotoxic and genotoxic impurities per ICH (including proficiency with in silico characterization using statistical and knowledge-based ICH/FDA-supported softwares), characterization of excipients, contamination management (e.g., MAC determination), and derivation of Permissible Daily Exposures (PDE), Allowable Daily Intakes (ADI) or equivalents.
      • Broad experience with Occupational Toxicology issues, including derivation of Occupational Exposure Limits (OEL) or equivalent, contribution to Material Safety Data Sheet (MSDS) or equivalent, familiarity with route-to-route and other accepted extrapolative methods.
      • Broad experience with the conduct of environmental risk assessments per current regulation for medicinal products.
      • Familiarity with in silico platforms (e.g., Lhasa, Leadscope, Meteor, OECD QSAR ToolBox, ToxTree, etc.) or willingness to learn these and similar applications.
      • Familiarity with search & retrieval strategies with relevant databases.
      • Excellent verbal communication and scientific writing skills.
      • Ability to interact effectively and tactfully with a variety of critical audiences within and outside the organization.
      • Sense of urgency.
      • Enjoys and thrives in a fast-paced, multi-tasked, and hands-on environment.

Keywords: Disability Solutions, Sacramento , Associate Director, Occupational & Product Quality Toxicology, Executive , Sacramento, California

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