Biosafety Officer and Select Agents Responsible Official Location:
Case Main Campus Regular/Temporary:
Regular Full/Part Time:
Full-Time Job ID:
Strong Internal Identified
A strong internal candidate has been identified.
The Department of Environmental Health and Safety at Case Western Reserve University supports and advances the teaching, learning and research activities at the university by promoting a safe and healthy campus environment. The university has a strong biosafety program in place. The Biosafety Officer and Select Agents Responsible Official will lead to continue the excellence of our program and to grow it even further. Our mission is to provide and coordinate programs and services that minimize safety, health, environmental, and regulatory risks in a manner consistent with fiscal and environmental stewardship. Through inspection, training, and outreach, you will ensure proper understanding of biosafety requirements and assure regulatory compliance within the university community. The Biosafety Officer is responsible for the regulatory roles of the Biosafety Officer/Responsible Official. This includes regulatory compliance, regulatory permitting, biosafety program development, training, auditing, accident investigation, recombinant RNA/DNA and CRISPER/CAS guidance for National Institute of Health compliance through IBC, IACUC, IRB. This position will also lead emergency response teams in a managerial role.
Manage the Biosafety compliance program including Occupational Health, Emergency Response, Laboratory Safety, Biological Containment, Regulatory Permitting, purchasing of and shipping of toxins and biological agents well las act as legal point of contact for Case Western Reserve University for ordering all biological materials. They will act on behalf of the university as the legal permit holder for ordering biological materials and biotoxins with ATCC, BEI, and related drugs. They will Manage the import and export programs for bioagents both domestically and internationally. They will Manage the procurement of permits from regulatory agencies such as NIH, CDC, APHIS, FDA and act as the legal representative for the university regarding these permits. They will manage the electronic inventory of all biological materials and toxins on campus and maintain system. They will Conduct biosafety-specific assessments of laboratories working at the BSL-2 and BSL-3 level including rDNA, RNA, infectious agents, and toxins. They will develop and deliver Biosafety training for all campus units. They will develop, maintain, and review OSHA Exposure Control Plans for all laboratories on campus. They will review protocols requiring department approval for submission to DoD, private research foundations or others as needed. They will provide technical assistance with all laboratory commissioning and decommissioning. They will provide technical assistance with the design of biological laboratories and HVAC systems. (40%)Working with regulatory agencies and partner institutions, conduct inspections as required for permitting and onsite inspection of laboratories including BSL3, ABSL3, BSL2, and other regulated laboratory spaces. They will conduct inspections in support of purchasing and permitting, conduct audits of BSL3 and Animal facilities for OSHA, CDC, NIH compliance, perform general laboratory inspections as needed, and conduct joint inspections of facilities shared by CWRU located in sister organizations. This will include inspections in support of Cleveland Clinic Foundation, MetroHealth Medical Center, Veterans Affairs, NASA and other institutions working in both the BSL3 and ABSL3 facilities. (30%)The BSO/ARO will Chair the BSL3 committee and actively engage the IACUC, IBC, IRB, COVID safety research, and Lab Safety Committees, and review procedures, protocols, safety measures. They will work with the University IBC, IACUC and other institutional compliance panels to ensure comprehensive reviews, and review submitted protocols and guide committees with regards to occupational health and containment concerns. Additionally, they will maintain required regulatory program standard operating procedures and manuals and update the department website in support of the biosafety program. (9%)Work with university occupational health staff to address exposure risks by participating in the review and analysis of exposure and incident reports related to Biosafety, including medical surveillance involvement. They will conduct accident investigations to determine root cause. They will work with Animal Resource Center in support of accreditation activities and support of their BSL3 facility. They will Manage the testing of Biosafety cabinets and related control equipment and the certification of sterilization autoclaves and ethylene oxide devices. 9%Lead emergency response including the direct management of staff as required. They are authorized to work directly with and to represent the university with external agencies including ODH, CDC, EPA, APHIS, USDA, NIH, Fire, Police, FBI, OSHA as required for Biosafety. They will take part in in an emergency response 24/7 on call schedule and respond as needed to incidents and will organize and conduct biosafety laboratory decontamination as well las after-action reporting and support activities. 6%Assure that the university Biowaste Program and Autoclave Program is compliant. This includes working with campus groups to assure that the request for proposal process for biowaste removal is complete and regulatory compliant. They will assure proper training of custodial, facilities, Police, Security and other university personnel. They will assure the proper use of sharps and other containment devices. They will assure the proper selection of biocides and their application. They will assure autoclaves are certified and running. 6%
Perform other duties as assigned.
Department: Frequent contact with the director and other staff.
University: Contact with senior administration, department heads and faculty, General Council, Research Administration, Medical school departments and others.
External: Contact with contractors, vendors, and regulatory bodies to resolve issues and represent the university
Students: Regular contact with students to provide training and instruction.
Will directly supervise staff members.
Experience: 8 to 10 years of related experience in biological research, compliance and/or biosafety
Education/licensing: Master’s degree in Biology or related field with an emphasis on microbiology, pathology, virology, and/or biosafety. Certified Biological Safety Professional/Registered Biosafety Professional preferred
- Excellent interpersonal and communication skills. Ability to interact with colleagues, supervisors, and customers face to face.
- Must be detail oriented.
- Excellent computer skills including experience with Microsoft Office Suite and the ability to learn new software.
- Highly motivated, self-starter who can identify and prioritize project.
- Ability to interact and work with faculty and staff at all levels while maintaining a professional disposition.
- Experience with high containment (BSL-3/4) laboratories.
- Experience running an IBC a plus
- Must demonstrate creative problem-solving skills.
- Ability to meet consistent attendance.
Typical office environment, walking, bending, laboratory/ (BSL2/3) environment, 24-hour emergency contact. Minimal travel required.
In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity. Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Equity at 216-368-3066 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.