About this role

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

<ul>

<li>Serve as a contact and subject matter expert on Biosafety, EHS policies and programs, including managing Institutional Biosafety Committees (IBCs), IACUC, Occupational Health.</li>

<li>Provide leadership in inspections, audits, and regulatory compliance efforts across laboratory and workplace environments.</li>

<li>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.</li>

<li>Demonstrated ability to apply core biosafety concepts, including criteria for establishing appropriate biosafety containment levels across diverse research and laboratory applications.</li>

<li>Demonstrated knowledge of recombinant DNA technology, viral vectors, and biological hazards.</li>

<li>Lead EHS program development, implementation, and continuous improvement, including policies, training, and compliance activities.</li>

<li>Direct incident investigations, risk assessments, and corrective action programs to mitigate hazards and improve safety performance. </li>

<li>Maintain expertise in biosafety, biological hazards, and applicable federal, state, and local regulations. </li>

<li>Understand regulatory changes and trends and forecast site impacts.</li>

<li>Working Relationships - Must demonstrate effective communication and develop working relationships with senior management, front line supervision, as well as other employees.</li>

</ul>

Required Qualifications

<ul>

<li>B.S. in Environmental/Health and Safety Science, engineering, or Applied Sciences degree is required.</li>

<li>Certification in an EHS related discipline and/or further education is a plus.</li>

<li>8+ years applied professional EHS work experience.</li>

<li>Knowledge of federal and state regulations, industry standards and best management practices pertaining to environmental health & safety.</li>

<li>Technical and practical knowledge of biotechnology, research, and development or a willingness to quickly become proficient is required.</li>

<li>Experience in implementing EHS programs, including Biosafety.</li>

<li>Ability to work with people in a culturally diverse environment.</li>

<li>Excellent communication skills (written, oral and presentation).</li>

<li>Lead initiatives of moderate scope and impact. </li>

<li>Ability to coordinate several projects simultaneously.</li>

<li>Effective problem identification and solution skills</li>

</ul>

Preferred Qualifications

<ul>

<li>Relevant professional certification(s) preferred including RBP, CBSP, P.E., CSP and/or CIH.</li>

<li>Working knowledge of GLP</li>

</ul>

Location and Working Environment

<ul>

<li>This position is based in South San Francisco, CA and will require on-site work at the Astellas West Coast Innovation Center.</li>

</ul>

What awaits you at Astellas?

<ul>

<li>Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. </li>

<li>Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.</li>

<li>Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. </li>

<li>A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. </li>

</ul>

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

<ul>

<li>Medical, Dental and Vision Insurance</li>

<li>Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down</li>

<li>401(k) match and annual company contribution</li>

<li>Company paid life insurance</li>

<li>Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions</li>

<li>Long Term Incentive Plan for eligible positions</li>

<li>Company fleet vehicle for eligible positions</li>

<li>Referral bonus program</li>

</ul>

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