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.
location: Durham, North Carolina
job type: Permanent
salary: $150,000 - 210,000 per year
work hours: 9 to 5
education: Doctorate
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.
qualifications:
- 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.
- Experience in project management, especially in the areas of plasma or biotechnology products
skills: Good Laboratory Practices (GLP), European Medicines Agency (EMA), Food and Drug Administration (FDA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
