Biological Safety Manager

Biological Safety Manager

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

Biological Safety Manager (EHS) is responsible for oversight and continuous enhancement of the Biosafety Program, including broader EHS program integration. This role manages the Institutional Biosafety Committee (IBC) and leads biosafety risk assessments. The position is based in South San Francisco, CA

Role and Responsibilities

• Serve as a contact and subject matter expert on Biosafety, EHS policies and programs, including managing Institutional Biosafety Committees (IBCs), IACUC, Occupational Health.
• Provide leadership in inspections, audits, and regulatory compliance efforts across laboratory and workplace environments.
• Professional knowledge of federal, state, and local regulations pertaining to CDC and NIH biosafety guidelines as they apply to infectious agents, recombinant DNA, and bloodborne pathogens.
• Demonstrated ability to apply core biosafety concepts, including criteria for establishing appropriate biosafety containment levels across diverse research and laboratory applications.
• Demonstrated knowledge of recombinant DNA technology, viral vectors, and biological hazards.
• Lead EHS program development, implementation, and continuous improvement, including policies, training, and compliance activities.
• Direct incident investigations, risk assessments, and corrective action programs to mitigate hazards and improve safety performance.
• Maintain expertise in biosafety, biological hazards, and applicable federal, state, and local regulations.
• Understand regulatory changes and trends and forecast site impacts.
• Working Relationships - Must demonstrate effective communication and develop working relationships with senior management, front line supervision, as well as other employees.