Astellas Pharma US, Inc

Biological Safety Manager

Astellas Pharma US, Inc$105K — $150K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in Environmental/Health and Safety Science, engineering, or related field required.
  • 8+ years of professional EHS experience necessary.
  • Knowledge of regulations and industry standards for environmental health & safety essential.
  • Technical understanding of biotechnology and willingness to learn required.
  • Experience implementing EHS, specifically biosafety programs, is essential.
  • Strong communication skills in diverse environments needed.
  • Ability to manage multiple projects effectively is crucial.

Responsibilities

  • Serve as the biosafety and EHS subject matter expert, overseeing IBCs and IACUC.
  • Lead inspections and ensure compliance with safety regulations in labs and workplaces.
  • Apply biosafety regulations from CDC and NIH to assess risks associated with biological agents.
  • Design and enhance EHS programs, including training and policy development.
  • Conduct incident investigations and risk assessments to improve safety.
  • Maintain up-to-date knowledge of regulatory trends affecting biosafety and compliance.
  • Foster collaborative relationships across various levels of the organization.

Benefits

  • Comprehensive Medical, Dental, and Vision Insurance
  • Generous Paid Time Off and national holidays available
  • 401(k) matching and annual company contributions
  • Company-paid life insurance
  • Performance-based bonuses and incentives
  • Long-term incentive plans for eligible roles
  • Access to a company fleet vehicle for qualifying positions
  • Incentives for employee referrals.
Full Job Description
Biological Safety Manager

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.


Required Qualifications
  • B.S. in Environmental/Health and Safety Science, engineering, or Applied Sciences degree is required.
  • Certification in an EHS related discipline and/or further education is a plus.
  • 8+ years applied professional EHS work experience.
  • Knowledge of federal and state regulations, industry standards and best management practices pertaining to environmental health & safety.
  • Technical and practical knowledge of biotechnology, research, and development or a willingness to quickly become proficient is required.
  • Experience in implementing EHS programs, including Biosafety.
  • Ability to work with people in a culturally diverse environment.
  • Excellent communication skills (written, oral and presentation).
  • Lead initiatives of moderate scope and impact.
  • Ability to coordinate several projects simultaneously.
  • Effective problem identification and solution skills

Preferred Qualifications
  • Relevant professional certification(s) preferred including RBP, CBSP, P.E., CSP and/or CIH.
  • Working knowledge of GLP


Location and Working Environment
  • This position is based in South San Francisco, CA and will require on-site work at the Astellas West Coast Innovation Center.


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:
  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
  • 401(k) match and annual company contribution
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Company fleet vehicle for eligible positions
  • Referral bonus program


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About Astellas Pharma US, Inc

Astellas Pharma US, Inc is a pharmaceutical company that develops and markets drugs for the treatment of cancer, immunology, and urology. The company is a subsidiary of Astellas Pharma Inc, a Japanese pharmaceutical company. Astellas Pharma US, Inc was founded in 2005 and is headquartered in Northbrook, Illinois. The company has over 17,000 employees and operates in over 50 countries. Astellas Pharma US, Inc is committed to improving the health and well-being of patients through the development of innovative and effective therapies.
Learn more about Astellas Pharma US, Inc
Size
14,522 employees
Industry
Founded
2005
NASDAQ

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