Senior Biological Safety Officer

Job description

We have an opening for a Senior Biological Safety Officer to aid in the development, implementation, and improvement of a comprehensive and compliant biosafety program at LLNL. In this role you will work closely with the Institutional Biological Safety Officer to ensure compliance with applicable federal, state, and local biological safety regulations and requirements, use data to develop corrective and preventative practices and procedures related to biological safety and provide senior expert-level support and guidance in the area of biosafety. You will interact with all levels of personnel throughout LLNL as well as outside agencies such as the Department of Energy (DOE), the Centers for Disease Control and Prevention (CDC), the United States Department of Agriculture (USDA) and other DOE contractor facilities. This position is in the Biosafety and Biogovernance Functional Area within the Environment, Safety and Health (ESH) Directorate. This position offers a hybrid schedule, blending in-person and virtual presence. You will have the flexibility to work from home one or more days per week. You will Develop and implement biosafety requirements, processes and procedures based on federal, state, and local biosafety regulations, institutional requirements, and industry best practices, in collaboration with the Institutional Biosafety Officer. Collaborate with principal investigators and research teams to conduct risk assessments of new and ongoing biological research activities, assist with the development of Biological Use Authorizations (BUAs), and provide technical guidance regarding equipment, facilities, and work practices for protection of personnel, laboratories, and the environment from biological hazards. Develop and implement emergency response procedures for incidents involving biological agents and materials. Investigate accidents involving biological agents and materials and develop corrective actions plans. Participate in planning renovation of existing space and design of new biological research buildings to ensure facility compliance with regulations and guidelines for work with biological agents and materials. Develop, improve, and implement a comprehensive biological safety training program. Cultivate strong, collaborative relationships with principal investigators (PIs), researchers, staff and line managers in directorates authorizing biological research to enhance biosafety practices, increase biosafety awareness and foster proactive risk management. Serve as an alternate voting member for the Institutional Biosafety Officer on the Institutional Biosafety Committee (IBC), Biological Review Committee (BRC), Institutional Animal Care and Use Committee (IACUC) and other committees, as appropriate. Serve as an Alternate Responsible Official (ARO) for the LLNL Select Agent Program and in the absence of the Responsible Official (RO), carry out all responsibilities of the RO to ensure compliance with the Federal Select agent Program; assist the RO with maintaining detailed records necessary to provide a complete accounting of all activities related to the use and/or transfer of select agents and perform audits and inspections of the BSL-3/ABSL-3 laboratories. Collaborate with and benchmark against other DOE sites to share practices and continuously improve. Develop additional leading indicators and metrics for the Biosafety Office to proactively identify programmatic risks and trends and incorporate them into ongoing program review and reporting processes. Develop a comprehensive biosafety manual, and review and update existing institutional biosafety policies, procedures, and program documents to ensure continued alignment with regulatory requirements and institutional practice. Provide overall programmatic oversight of biosafety training, ensuring curricula remain current with regulatory changes and institutional policy updates and that compliance is tracked across the institution. Compile and analyze biosafety program data to prepare semi-annual and annual reports for institutional leadership and applicable regulatory and oversight bodies and use findings to inform continuous improvement. Perform other duties as assigned. Ability to secure and maintain a U.S. DOE Q-level security clearance which requires U.S. citizenship and a Federal Bureau of Investigation (FBI)/Criminal Justice Information Services (CJIS) Security Risk Assessment (SRA) for access to Tier 1 select agents, ability to become medically qualified to wear a respirator and ability to secure and maintain certification in the Select Agent Human Reliability Program (SAHRP) which includes: physical and psychological assessment and random drug and alcohol testing. PhD degree in Microbiology, Virology, Immunology, Pathology, Molecular/Cellular Biology, or related field and substantial experience working with direct laboratory research experience at the BSL-2 containment level working with infectious biological agents/materials or equivalent level of demonstrated knowledge and relevant previous experience. Ability to become medically qualified to wear a respirator. Substantial experience providing highly advanced technical guidance for the control of biological hazards using knowledge of applicable federal, state and local biosafety regulations, standards, and policies [e.g., Biosafety in Microbiological and Biomedical Laboratories (BMBL), National Institutions of Health (NIH) Guidelines, OSHA Bloodborne Pathogens Standard]. Substantial experience with highly complex safety audits/inspections of biological research laboratories for compliance with biosafety requirements, preparing technical reports, identifying corrective actions and correcting compliance issues which may include factors that are not well defined. Substantial experience building strong working relationships and trust with the regulated biological research community and a demonstrated collaborative approach to establishing and maintaining a shared co