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About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Health insurance
- Paid time off
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pathogen safety strategiesproject planningbudget controlrisk assessmentsregulatory documentationGMPGLPbiological processingvirologybiochemistry
Soft Skills
leadershipmanagementcross-functional coordinationcommunicationevaluationinterpretationreportingteam collaborationsafety culture
Certifications
Ph.D.M.D.
