Senior Director, Product Quality/Occupational ToxicologistApply Now

Category: PK/PD
Location: Sf Bay Area - Philadelphia, PA
Salary: TBD

Job Description:

Description: The Senior Director, Product Quality and Occupational Toxicology 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 our 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 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 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 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

Job Requirements:

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 Environmental 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.

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