Director, Pathogen Safety

Director, Pathogen Safety

Location: NC-RTP, US Contract Type: Regular Full-Time Area: R & D

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary: Director of Pathogen Safety is a senior leadership role responsible for defining and executing pathogen (viral) safety strategies for new and existing biotherapeutic products. The position leads global projects across R&D and 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 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.