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Associate Director, Occupational & Product Quality Toxicology

5-7 years
$156,800.00 - $235,200.00
10 July 29, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Jazz Pharmaceuticals: Innovating for Patient Well-Being

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a leading global biopharmaceutical company dedicated to innovating life-changing medicines for people with serious diseases, often those with limited or no therapeutic options. Our diverse portfolio includes marketed medicines and novel product candidates in neuroscience and oncology, spanning from early to late-stage development. We are committed to exploring new therapeutic avenues, including novel compounds, small molecules, biologics, cannabinoid science, and innovative delivery technologies. Headquartered in Dublin, Ireland, Jazz Pharmaceuticals operates worldwide, serving patients in nearly 75 countries. Learn more at www.jazzpharma.com and follow us on Twitter @JazzPharma.

Position: Associate Director, Occupational and Product Quality Toxicology

Role Overview

The Associate Director of Product Quality Toxicology (PQT) at Jazz Pharmaceuticals plays a critical role in ensuring the safety and quality of our products throughout their lifecycle. This includes assessing health and safety risks associated with handling chemicals, drug formulations, excipients, and impurities in our products, and conducting environmental risk assessments to support regulatory submissions and marketing approval. This position requires extensive collaboration with various departments, including Technical Operations, Global Quality, and Regulatory Affairs, to address product quality and occupational and environmental health aspects across Jazz's product portfolio. The Associate Director will serve as the primary point of contact for toxicological issues, provide expertise in responding to regulatory inquiries, and contribute to the development of standard operating procedures and strategic initiatives within the Toxicology Department.

Key Responsibilities

  • Provide toxicological hazard and risk assessments to support product quality, occupational, and environmental health.
  • Lead evaluations of health risks associated with drug formulations, excipients, impurities, and other product quality aspects.
  • Conduct and review environmental risk assessments to support NDA/BLA/MAA submissions.
  • Develop and oversee standard operating procedures, processes, and templates within the Toxicology Department.
  • Collaborate with stakeholders to create Material Safety Data Sheets (MSDS) for Jazz commercial products.
  • Provide strategic and tactical leadership in compliance with corporate policies and global regulatory requirements.
  • Support the Toxicology team in addressing product quality-related concerns, such as impurity specifications and excipient evaluations.
  • Maintain current knowledge of relevant scientific literature and methodologies related to occupational and environmental toxicology.

Qualifications

  • 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 sit for the certification exam is desirable.
  • Extensive experience in assessing non-genotoxic and genotoxic impurities, excipient characterization, contamination management, and deriving exposure limits (PDE/ADE, OEL).
  • Experience in environmental risk assessments in compliance with current regulations.
  • Familiarity with in silico platforms (e.g., Lhasa, Leadscope, Meteor, OECD QSAR ToolBox, ToxTree) and database search and retrieval strategies.
  • Strong verbal communication and scientific writing skills, with the ability to interact effectively with diverse audiences.
  • A proactive and flexible approach, with the ability to thrive in a fast-paced, multitasked environment.

Compensation and Benefits

For U.S.-based candidates, the base pay range for this position is $156,800.00 - $235,200.00, with individual compensation dependent on qualifications, skills, experience, and job knowledge. In addition to base pay, employees may be eligible for discretionary annual bonuses, incentive compensation, and equity grants. Jazz Pharmaceuticals offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation. For more information on our benefits, please visit Jazz Pharmaceuticals Benefits.

EEO Statement

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.