Biosafety Officer and Select Agents Responsible Official

Job Details

Job Title: Biosafety Officer and Select Agents Responsible Official
Location: Case Main Campus
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 8971
Strong Internal Identified

A strong internal candidate has been identified.

Job Description

POSITION DESCRIPTION

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.

ESSENTIAL FUNCTIONS

    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%

NONESSENTIAL FUNCTIONS

Perform other duties as assigned.

CONTACTS

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.

SUPERVISORY RESPONSIBILITIES

Will directly supervise staff members.

QUALIFICATIONS

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

REQUIRED SKILLS

  1. Excellent interpersonal and communication skills. Ability to interact with colleagues, supervisors, and customers face to face.
  2. Must be detail oriented.
  3. Excellent computer skills including experience with Microsoft Office Suite and the ability to learn new software.
  4. Highly motivated, self-starter who can identify and prioritize project.
  5. Ability to interact and work with faculty and staff at all levels while maintaining a professional disposition.
  6. Experience with high containment (BSL-3/4) laboratories.
  7. Experience running an IBC a plus
  8. Must demonstrate creative problem-solving skills.
  9. Ability to meet consistent attendance.

WORKING CONDITIONS

Typical office environment, walking, bending, laboratory/ (BSL2/3) environment, 24-hour emergency contact. Minimal travel required.

Diversity Statement

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.

Reasonable Accommodations

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.

Organization

Working at Case Western Reserve University

Case Western Reserve University is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case Western Reserve is distinguished by its strengths in educationresearch, service and experiential learning. Located in Cleveland's University Circle, we offer nationally recognized programs in the arts and sciencesdental medicineengineeringlawmanagementmedicinenursing and social sciences.

Student enrollment exceeds 9,800 students, forty percent of whom are undergraduatesFacultyand students hail from more than 90 countries, with academic interests that reach every region of the world. Case Western Reserve, with the support of individuals, corporations and foundations, aids nearly 100 designated research centers.

As a service-oriented institution dedicated to civic leadership, Case Western Reserve seeks individually and collectively to prepare our students to improve the human condition and to direct the benefits of discovery toward a better society. This effort is not limited to the university's classrooms, laboratories, librariesresidence halls and athletic fields, but includes partnerships with many other institutions. We build these partnerships believing that our ability to improve the human condition should begin in our own community.

Case Western Reserve University remains Ohio's top-ranked school among the nation's premier national universities, as ranked by U.S. News & World Report and is the only Ohio institution ranked in the top 50 nationally. We promote a culture of inquiry marked by rigor, creativity, curiosity, innovation, respect, sensitivity and open communication of ideas.

The university supports interdisciplinary partnerships in education and research with numerous faculty holding joint appointments in more than one Case Western Reserve school or department, as well as at neighboring institutions. These relationships launched many of the unique pairings of science, business and liberal arts into the centers and programs that enhance the undergraduate and graduate experience at the university. Our dual degree programs enrich the educational experience for those students who choose to balance the technical requirements of engineering or the sciences with a strong interest in the humanities.

With more than $375 million in research funding annually, the university attracts outstanding undergraduate and graduate students along with renowned faculty whose research has made significant contributions to the way we live and work. Case Western Reserve counts 15 Nobel laureates among our alumni and current and former faculty, including the first American scientist to ever receive the prize.

Our students' experiences in cultural institutions, clinics, social service agencies and industry are not viewed as “extra-curricular,” but create the learning experience that defines a Case Western Reserve education. The university's service programs in the Cleveland Municipal School District have impacted more than 145,000 students with more than 43 signature programs. The university has launched more than 580 community partnerships on the local, national and international levels. Annually the university sponsors Case for Community Day, an event where hundreds of Case Western Reserve employees and students lend their time and talent to targeted community development projects in the Greater Cleveland area.

Our alumni number more than 110,000 and constitute a “who's who” of every profession. Alumni represent one of the university's strongest resources, playing a vital role in campus life through their work as advisors, mentors, friends and advocates.

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