Director, Pathogen Safety

Summary

The Director of Pathogen Safety is a senior leadership role responsible for defining and executing pathogen (viral) safety strategies for new and existing biotherapeutic products. This position leads global projects across Research and Development (R&D) and Chemistry, Manufacturing, and Controls (CMC), ensuring scientific excellence, regulatory compliance, and alignment with state-of-the-art technologies while meeting company objectives and timelines.

Primary responsibilities

- Lead and manage pathogen safety strategies and studies for product development and lifecycle management. - Act as Study Director or site responsible for internal and external pathogen safety studies in GLP and non-GLP environments. - Oversee project planning, execution, budget control, and cross-functional coordination within multidisciplinary teams. - Evaluate and interpret pathogen safety study results, reporting progress to project teams and R&D management. - Prepare, review, and approve technical reports, risk assessments, and regulatory documentation supporting registration dossiers. - Ensure full compliance with GMP, GLP/BPL, quality, safety, and environmental standards, and promote a strong safety culture.

Knowledge, Skills, & Abilities

- Experience in project management, especially in the areas of plasma or biotechnology products. - Proven ability to take a strong leadership role in organizational issues. - Experience in managing strategic and operational aspects of relationships with internal and external partners. - Ability to make appropriate judgments on safety policy and compliance. - Team player with excellent communication skills. Able to effectively communicate sensitive issues both inside and outside the organization.

Requirements

- Advanced scientific degree, Ph.D. or M.D. - 10+ years experience in Pharmaceuticals and biotechnology with experience in one or more of the following areas: quality assurance, biological processing, virology, biochemistry, and biotechnology development. Background in virology, TSE and viral clearance study design desired.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.