Institutional Biosafety Program Manager

About the role

The Institutional Biosafety Program Manager will lead the development, implementation, and continuous improvement of LLNL's institutional biosafety program. This role involves managing biological research, laboratory animal research, and related institutional review activities, ensuring they are conducted safely and in compliance with applicable regulations.

Responsibilities

• Manage and continuously improve LLNL’s institutional biosafety program, policies, procedures, and program documentation.
• Provide expert technical guidance on biosafety, biosecurity, biological research risks, containment concepts, and laboratory operations.
• Develop program strategies, priorities, performance objectives, and resource requirements aligned with Laboratory mission needs.
• Lead risk assessments for new and ongoing biological research activities and support development of Biological Use Authorizations.
• Oversee biosafety reviews involving biological agents and materials, including activities conducted at BSL-1 through BSL-3 and ABSL-1 through ABSL-3 containment levels.
• Ensure compliance with applicable requirements and industry standards, including Biosafety in Microbiological and Biomedical Laboratories, NIH Guidelines, OSHA standards, DOE requirements, and other applicable federal, state and local regulations.
• Serve as the Institutional Biosafety Officer and participate as a voting member of the Institutional Biosafety Committee, Biological Review Committee, Institutional Animal Care and Use Committee and Institutional Review Entity.
• Serve as an institutional technical liaison with DOE, the DOE Livermore Field Office, USDA, and other regulatory or oversight organizations.
• Oversee biosafety audits, inspections, assessments, investigations, corrective actions, and continuous improvement activities.
• Develop and maintain emergency response procedures for incidents involving biological agents and materials.
• Oversee institutional biosafety training, including curriculum development, regulatory updates, delivery, and compliance tracking.
• Establish and maintain data-driven performance measures, leading indicators, and program health metrics.
• Compile, analyze, and communicate biosafety program information for leadership, oversight bodies, committees, and regulatory agencies.
• Build collaborative relationships with principal investigators, researchers, line managers, staff, committees, and external stakeholders.
• Benchmark biosafety practices with other DOE laboratories and research institutions.
• Lead, mentor, and develop biosafety professionals and other program personnel, as assigned.

Requirements

• Ability to secure and maintain a U.S. DOE Q-level security clearance, which requires U.S. citizenship.
• PhD in biology, microbiology, molecular biology, virology, immunology, or a related life sciences field, or an equivalent combination of education and substantial relevant experience.
• Extensive experience managing or leading institutional biosafety programs in a research laboratory, biotechnology, government, or comparable environment.
• Expert knowledge of biosafety principles, laboratory operations, pathogenic microbiological techniques, biological containment, and biological hazard controls.
• Expert knowledge of applicable biosafety regulations, standards, and guidelines, including BMBL, NIH Guidelines, OSHA Bloodborne Pathogens requirements, and relevant DOE requirements.
• Substantial experience with biosafety or voting membership in relevant biogovernance committees such as IBC, IRE, IACUC, or equivalent committees.
• Demonstrated experience conducting or overseeing biological research risk assessments, laboratory inspections, audits, incident investigations, and corrective action programs.
• Experience developing policies, procedures, training programs, performance measures, reports, and other institutional program documents.
• Demonstrated ability to interpret highly complex or ambiguous regulatory requirements and apply them across diverse research and operational environments.
• Experience managing resources, projects, priorities, budgets, or personnel within a complex organization.
• Excellent communication, facilitation, collaboration, negotiation, presentation, and conflict-resolution skills.
• Strong analytical, organizational, situational awareness, problem-solving, and decision-making skills.
• Demonstrated ability to build trust, gain consensus, and influence personnel at all levels while maintaining high standards of safety and compliance.

Qualifications

• Current certification or registration through the American Biological Safety Association, such as Certified Biological Safety Professional or Registered Biosafety Professional.
• Experience working at the BSL-3 or ABSL-3 containment level.
• Knowledge of CDC and USDA import, export, transport, and permit requirements.
• Experience with biological security, biosecurity, or biological risk management.
• Experience with DOE directives, orders, laboratory operating contracts, or other federal research requirements.
• Experience supporting the design, commissioning, or renovation of biological research facilities.
• Experience developing data-driven program metrics and communicating program performance to senior leadership.
• Experience supervising, mentoring, recruiting, or developing biosafety professionals.
• Experience leading biosafety programs in a national laboratory or other highly regulated research environment.

Pay

$240,960- $305,544 Annually