Jazz Pharmaceuticals

Senior Director - Product Quality/Occupational Toxicologist

US-CA-Palo Alto
1 month ago
Job ID
2017-1282
# of Openings
1
Category
Research & Development

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

Jazz Product Quality and Occupational Toxicology (PQOT) is responsible for providing robust, scientifically-sound hazard and risk assessments to support product quality activities, primarily associated with manufacturing, and health and safety of the workplace for employees handling proprietary and non-proprietary chemicals used in the production of Jazz products.

The Senior Director is primarily accountable for product quality/occupational toxicology, working in collaboration with nonclinical toxicology, TechOps, Global Quality to drive the overall global regulatory strategy and coordination of product quality/occupational toxicology for multiple Jazz portfolio products, from research to registration and beyond.  The individual has experience in evaluating and responding to product quality/occupational toxicology inquiries from global regulatory authorities in support of major submissions and commercial batch release.  The individual represents the department at the project team level while directing outsourced activities in collaboration with study monitors and project managers, to enable timely high-quality project deliverables.

Essential Functions

tactical and strategic leadership in compliance with corporate policies and standards and global regulatory requirements

advising project teams on product quality-related concerns (e.g., specifications for known impurities, evaluation of leachables/extractables,

assessment of potential genotoxic impurities;

authoring human health risk assessments required for small and large molecule manufacturing (e.g., determination of permissible/acceptable daily exposure (ADE/PDE),

occupational exposure limit (OEL), and

maximum allowable carryover (MAC) values);

co-authoring material safety data sheets for Jazz commercial products in collaboration with CMC;

oversight of environmental risk assessments that NDA/BLA; and

addressing other relevant issues on an ad hoc basis.

Responsible for review of scientific and strategic aspects of risk assessments prepared by others prior to finalization and regulatory submission.

Responsible for upholding Jazz Standards related to Product Quality/Occupational toxicology in compliance with US and ex-US guidelines

Developing standard operating procedures, departmental processes and templates, as-needed

Required Knowledge, Skills, and Abilities

This is a highly interactive position within a cross-functional matrixed environment. This position requires a solid proficiency in a broad variety of scientific (e.g. toxicological) and technical skills to perform hazard/risk assessment, hazard communication, and other toxicology-based assessments in accordance with compliance to departmental, corporate, and regulatory requirements.

Required/Preferred Education and Licenses

  • Ph.D. in Toxicology or Environmetal Sciences required with 10-15 years of industry experience in biologics and pharmaceutical product quality. DABT required.

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and 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.

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