Working title:

Biological Safety Officer

Official title:

ASST DIR, UNSPEC (10)(M96LN)

Degree and area of specialization:

Applicant must meet one of the following requirements:

Master's degree from an accredited institution of higher education in one of the following: Microbiology, Molecular Biology, Mycology, Medical Technology, Biotechnology Sciences, or Science; plus five years of professional experience in managing biological safety and general laboratory programs; five years experience working in an academic research laboratory environment or in a biotechnology research/development laboratory environment; a working knowledge of biosafety regulations established by NIH, ORDA, CDC, USDA, OSHA, DOT, DHS, EPA, and Responsible Conduct of Research regulations and guidelines.

OR

A Bachelor of Science (B.S.) in one of the following: Microbiology, Molecular Biology, Occupational and Environmental Health Biology/Zoology, Medical Technology, or Health Sciences; plus ten years of progressive professional experience in managing or directing biological safety programs with similar responsibilities as described above, preferably at an academic institution with a large teaching /research medical center.

License/certification:

Professional certification as a Certified Biosafety Professional is highly desired.

Minimum number of years and type of relevant work experience:

See degree requirements.

Principal duties:

POSITION SUMMARY

Under the administrative supervision of the Director of Environment, Health and Safety (EH&S), the Assistant Director/Biological Safety Officer is responsible for managing and directing the biosafety program for the UW-Madison campus, offsite research facilities and EH&S contract services, including the University of Wisconsin Hospital and Clinics (UWHC).

This position supervises four professional biosafety staff, and is responsible for developing, supporting, and promoting programs necessary to maintain safe conduct of biological research. In consultation with the EH&S Director and the Institutional Biosafety Committee (IBC), the Biosafety Officer (BSO) oversees policies, procedures, programs, and services to ensure compliance with applicable federal, state, and institutional requirements. The BSO develops laboratory emergency response operating procedures for incidents involving biohazardous agents, and contributes to the central campus crisis preparedness and emergency response operations center.
Administratively, this position works closely with the director¿s leadership team, and with program staff to provide consultative services to faculty and staff, including supervisors and employees in Facilities Planning and Management (FP&M), Environment, Health and Safety, University Police, and the local HAZMAT Team. The BSO works closely with the EH&S director, several faculty committees, and Graduate School administrators to negotiate policies for the university and interpret these into goals and objectives for the department.
The BSO serves the Chair of the IBC by actively coordinating and participating in review of research protocols submitted to the Office of Biological Safety on behalf of the IBC. The BSO and staff thoroughly assess the risks posed by the proposed research and the acceptability of the physical and procedural containment measures. Included for review are proposals employing recombinant techniques subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules (Guidelines), infectious microorganisms (including select agents), and potentially biohazardous materials, in in vivo and in vitro investigations.
The BSO is a member of the IBC and is responsible for leading EH&S administrative support services for this committee, including organizing meetings, maintaining records, and providing other direct support. The BSO, in consultation with the director, serves as liaison with local, state, and federal agencies on all biosafety matters, as needed. Notices and publications are prepared and kept up-to-date to communicate key information to stakeholders.
The BSO provides consultation and serves as biosafety program liaison to campus research safety committees, research support organizations, and other administrative units as well as individual faculty and staff. Consultative services include performing biological safety risk assessments, research protocol review, support for design, modification, and maintenance of facilities and engineering controls for physical containment of biological hazards associated with campus research. The position leads and participates in developing and presenting courses/seminars for faculty and research staff in biosafety-related areas, and training for support staff whose work may bring them in contact with biohazards.

The BSO works with EH&S departmental staff and teams to promote and protect the individual health and safety of individuals who work or study on the UW-Madison campus and specific off-site facilities with a special emphasis on review of research involving potentially infectious microorganisms, select agents/toxins and, monitoring field application of APHIS-approved genetically modified organisms and microbiological assurance, and research involving recombinant DNA molecules and biotechnology.

The BSO will work collaboratively with co-workers and sponsored programs in Environment, Health and Safety and Facilities Planning and Management, with university faculty, staff and students, with colleagues throughout the University of Wisconsin System and with external agencies. The person in this position must be skilled in the evaluation, recognition and control of biological hazards and post exposure service coordination and management. Experience in risk communication and strong interpersonal skills will be required in order to build effective working relationships, negotiate and problem solve with multiple constituencies.

Established in 1848, the University of Wisconsin ¿ Madison is one of the country¿s first land grant universities, currently serving over 40,000 students and 18,500 faculty and staff. The main campus is comprised of over 900 acres of picturesque grounds along the shores of Lake Mendota, of which 325 acres are defined as the campus natural areas and are protected from development. The campus has over 18.5 million gross square feet of building space and offers a broad array of undergraduate, graduate, professional, research and advanced academic programs. The UW-Madison is the flagship university in the 26 campus University of Wisconsin System and one of the nation¿s largest and most productive research institutions in higher education, receiving over 703 million dollars in research funds in 2006-2007.

The Division of Facilities Planning and Management (FP&M) is committed to promoting respect and civility in the workplace. Staff serve as role models by practicing exemplary behaviors when working with customers, fellow staff members, students, and visitors. The mission of Facilities Planning and Management is to provide a physical environment which supports learning, working, living and playing. The organization is committed to stewardship of architectural, environmental, archeological and land resources in support of the academic and strategic objectives of the University of Wisconsin-Madison. The Office of Biological Safety collaborates with other EH&S Departmental offices and their staff to foster safe laboratory practices and ensures implementation and compliance with policies, guidelines, and regulations set forth by the university administration, the Institutional Biosafety Committee, regulatory agencies, and other campus research committees appointed by the UW ¿ Madison Chancellor .


Position Responsibilities

50% A. Biological Safety Program Management and Protocol Review

Direct the planning, development and administration of EH&S biosafety services including the following *:

1. Administer the Institutional Biosafety Committee (IBC)
2. Oversee biosafety research protocol processing and record management system.
3. Ensure compliance with NIH Biological Safety and recombinant DNA Guidelines
4. Provide consultative support services
5. Conduct scheduled lab consultations (audits)
6. Negotiate, develop, track, maintain, and report OBS Performance Metrics
7. Program staff and office management
* see appended detailed descriptions of these six points

Develop programs, policies and procedures for the safe use of hazardous biological materials in research and teaching laboratories. Management responsibility includes implementation of the EH&S staff development program, department strategic plans, and divisional initiatives.

Manage the Biological Safety program and facilitate the implementation of biosafety programs including identifying measurable performance metrics, monitoring the use of specific infectious agents in research laboratories, verifying compliance with applicable regulations, and developing corrective action plans and reports as necessary.

Manage the overall performance of the biosafety program, establish and communicate performance expectations, evaluate and measure effectiveness of programs, and maximize efficiency through the use of information technology.

Represent and negotiate with regulatory officials, as instructed by the EH&S Director, to ensure compliance with federal, state and local health, safety and environmental rules and regulations. Ensure compliance with University policies and procedures, and the expectations or requirements established by research safety committees, grant and accreditation agencies. Coordinate compliance with the Centers for Disease Control and Prevention (CDC) regulations (e.g., 42CFR Part 72) for facilities transferring or receiving select microbial agents. Maintain contact with the CDC Office of Biosafety, Office of Recombinant DNA Activities, NIH¿s Office of Recombinant DNA Activities and Safety Office concerning current recommendations for handling specific infectious agents. Evaluate the impact of new or proposed regulations and modify existing programs, services or procedures as necessary.

Assist researchers in obtaining the required permits (e.g. USDA-APHIS; CDC) for importing or shipping etiologic agents or regulated articles as well as field application of genetically modified plants/organisms.

Oversee the purchase of field service equipment, supplies, and the routine maintenance and calibration of instrumentation, sampling devices, and containment laboratory decontamination systems. Oversee the procurement, review and project management of contracts and service agreements with EH&S customers and vendors. This position works with the EH&S director and FP&M business staff to establish and monitor the budget for biological safety, monitors and approves purchasing for the program area and complies with all associated policies and procedures.

Supervise OBS customer service delivery including the timely investigation of customer, employee and/or external complaints and the identification, implementation of corrective action, and customer service follow-up. Supervise and conduct comprehensive facility inspections, design reviews and on-site surveys for ensuring proper performance of specialty containment facilities, equipment, regulated biological agent shipping and training, and transportation and the identification, evaluation, control and correction of biological hazards.

Provide consultative and administrative support to the UW-Madison Institutional Biological Safety Committee (IBC), a faculty committee appointed to fulfill a National Institutes of Health (NIH) mandate for institutions receiving NIH funding. This position will participate in a biosafety group effort directed at gathering information, analyzing data and proposing solutions. This position selects protocols for review and introduces institutional policy issues for IBC consideration and provides administrative support to the IBC. Maintain contact with UW research intramural grant administrators as well as external granting agencies regarding IBC approval of projects including those overlapping with other UW research committees.

Provide oversight of biological research safety and institutional compliance via the protocol review process. Protocols are required for 6 specific criteria including recombinant DNA activities (extending to human gene therapy trials) and hazardous biological materials. Screen rDNA registration submitted by investigators to the IBC to determine if experiments are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules (Guidelines) and require Committee review. Verify containment levels and applicable section of Guidelines cited by the investigator and prepare for review by the IBC. Position requires knowledge of state and federal guidelines and regulations and best practice pertaining to research involving recombinant DNA molecules (rDNA). Agencies involved include NIH, USDA-APHIS, EPA, FDA, DOT, Wisconsin DATCP and Wisconsin DNR.

Review research protocols to identify health risks, recommend decontamination agents and method efficacy, and biohazardous waste disposal including the autoclave program. Work with employees, supervisors, principal investigators and others to understand research needs, negotiate changes in work practices to ensure provision of a high standard of biosafety services and consistent operating procedures to protect faculty, staff, students, campus visitors, the environment, and support research and teaching objectives.

Conduct risk assessments of described research, and advise investigators of containment recommendations for research involving specific microorganisms. Consult with and advise investigators on laboratory safe science practices, personal protective equipment, medical surveillance requirements, containment facility design, specialty safety equipment, decontamination, disposal, use of appropriate signage, specific emergency response actions, and application of guidelines. Monitor field application of APHIS approved regulated genetically modified organisms

Support the select agent program, including complete oversight of aspects of biosafety, tracking personnel, consult on NIH laboratory security issues, incident response, occupational exposures. Provide administrative support for the Responsible Official.

Collaborate with animal care veterinarians and supervisors on research projects requiring animal facilities capable of providing biohazard containment and recommend preferred biohazardous waste disposal methods.

Oversee maintenance of current data pertaining to the research protocol process, reviews and investigations.

Participate in the deployment and use of the Click Commerce on-line research protocol management process.

Prepare special and periodic technical papers and reports for use in University planning, IBC work, or for distribution to regulatory and/or accrediting agencies. Coordinate the preparation of quarterly and annual reports, periodic guidelines or articles, manuals, newsletters, alert bulletins, presentations, website and other written, oral and electronic communications.

Inform the EH&S Director of program status at regularly scheduled progress meetings, and immediately in cases of emergency or compliance issues.

15% B. Supervision of Staff

Recruit, hire, train, evaluate performance, and coach OBS staff in compliance with applicable EH&S, division and university personnel policies and procedures.

Establish and communicate performance expectations, prioritize and balance workloads, provide frequent feedback and coaching, conduct annual performance evaluations, write and revise position descriptions for staff. Work with staff to identify professional development needs and opportunities. Consult with Director and FP&M Personnel on performance or competency issues and take corrective action, including disciplinary action when required, in a timely manner.

Promote respect and civility in the workplace. Demonstrate respect through personal behavior, developing positive working relationships with staff, students, customers and colleagues.


15% C. Department and Team Responsibilities

Demonstrate a commitment to organizational success, effectively managing change and initiating improvements in the processes and culture of the department.

Coordinate the direction and activities of OBS programs with EH&S program supervisors. Collaborate with the EH&S director¿s leadership team to align services, share staff resources and ensure coordinated, efficient and timely customer service. Participate in the development and administration of EH&S departmental policies and procedures.

Participate in the EH&S emergency response on-call program, provide on-site technical support and assume pre-assigned EH&S role to support the University¿s Emergency Operation Center during drills or activation as necessary. Participate in biosafety related in post-incident evaluations and reporting.

Work with other EH&S areas to develop and maintain a program to register new laboratories and decommission labs as research efforts change. Develop procedures and schedules for annual inspections of laboratories. Provide resources and coordinate with other EH&S departments on laboratory audits to improve response and reduce duplication of effort.

Participate in, and provide staff resources for EH&S and FP&M team-based projects including safety and compliance consultations (audits and inspections), training (including web-based delivery), construction project plan review, etc. The BSO will be responsible for sponsoring teams, allocating resources and when appropriate, serving as leader or member of teams. This position will be involved in initiating, staffing, monitoring and evaluating teams formed to complete a specific project, as well as long standing teams designed to provide coordinated services to campus.
Serve as a resource/contact person regarding state, federal, accrediting and other agency regulations and guidelines related to biological safety. When new regulations or guidelines are released for public comment, lead the effort to understand the impact on the university community and develop a response that fulfills the intent of the proposal while minimizing unnecessary interference with the work of the campus.

As assistant director, this position has increased responsibility in working with the Director and other assistant directors in setting strategic direction for the department and in establishing coordinated work plans aligned with that direction. This position will represent the EH&S department on biological safety issues with other UW-Madison and System departments, state agencies and regulatory bodies. When requested, this position will serve as acting Director, providing leadership to all areas of the department.

10% D. Training

Develop, coordinate and conduct training programs for researchers, EH&S staff, and other members of the campus community in the area of biological safety. Topics include, but are not limited to:
¿ Laboratory biosafety practices and procedures
¿ Animal biosafety
¿ Safe work practices for maintenance, custodial and other support staff in work areas with biosafety concerns.
¿ Proper use of containment equipment, autoclaves, and related emergency response
¿ Regulatory aspects of recombinant DNA technology

Promote and participate in in-service training, new employee orientation, continuing education, professional development and technical conferences to keep abreast of best practices in the areas of management and biological safety.

10% E. Projects and Special Assignments

As assigned, develop and implement solutions to issues outside the scope of the biological safety program area. Duties may include assisting other departments such as Legal Services, UW Police, University Health Services, Risk Management, and Madison Fire Department.

Perform other duties as assigned.


* Supplemental Biosafety Program Management Responsibility Descriptions

A (1) Administer the Institutional Biosafety Committee
Serve as chief administrative officer for the IBC and ex officio voting member.
Coordinate activities associated with monthly IBC meeting. These activities typically include:
- Select protocols and other business for the agenda; assign primary and secondary reviewers for each protocol. Distribute meeting materials.
- Provide support to the committee chairman in conducting the meeting.
- Record the committee deliberations and prepare minutes.
- Notify Principal Investigators of the results of IBC review. Ensure closure on outstanding requirements prior to issuing the registration form.
- Prepare institutional policies and procedures for review and adoption by the IBC. Communicate IBC policies and procedures to stakeholders.
- Report to the EH&S Director, the IBC and the institution any significant problems, violations of the Guidelines and research-related accidents or illnesses of which the Biological Safety Officer becomes aware.
- Direct the effort to maintain records and current data regarding work of the IBC.

A (2) Oversee Biosafety Research Protocol Processing
Periodically evaluate the criteria for which a protocol must be submitted and the biosafety protocol template to ensure optimal collection of data regarding research with infectious and recombinant materials. Recommend changes for improving the criteria, template, and other aspects of protocol management to the IBC for adoption by the institution.
Screen submitted biosafety protocols to determine if experiments require IBC review per the criteria described in the IBC Handbook. Criteria for IBC review include but are not limited to protocols describing research that is subject to Section IIIA-D of the NIH Guidelines for Activities Involving Recombinant DNA Molecules (Guidelines).
Conduct a risk assessment of the research described in the protocol based on institutional policies and federal standards per the Guidelines, BMBL, and APHIS requirements.
- Assess the adequacy of the facilities, procedures, practices, training and expertise of personnel involved in the proposed research
- Assign the appropriate containment level for the described activities
- As needed, contact investigators to obtain revision of the protocol or additional information to enable informed risk assessment.
- Ensure that the laboratory is in compliance with other related safety and health regulations.
- Register (approve) those protocols that are found to conform to institutional and federal standards. Communicate the risk assessment to the Principal Investigator.

A (3) Consultative Services
Serve as liaison on biological safety matters between investigators, the IBC and other research support groups (e.g. EH&S programs, Research Animal Resource Center, Research and Sponsored Programs), faculty safety committees (e.g. Chemical, Radiation, and Occupational Health committees), Institutional Animal Care and Use Committees, Human Subjects Committees), and state and federal agencies.
Provide advice concerning required and best practices for containment (Biosafety Level) of infectious and recombinant materials to Principal Investigators, the IBC, and laboratory workers including those involved in animal care. Also provide advice regarding equipment selection, decontamination and disposal procedures, and appropriate signage to assure the safe and compliant conduct of research.
Provide consultative support to UW-Madison planning, design and construction groups in the research, design, development and modification of engineering controls for containment of biological hazards associated with campus research, particularly in the biological sciences, as they pertain to new facilities as well as to existing campus facilities.
Predict research trends and forecast facility requirements and needs that may impact the scope of UW Madison investigations requiring biocontainment.
Conduct or supervise all testing programs designed to demonstrate the integrity of containment equipment and facility safeguards except certification of biological safety cabinets. Collaborate with the Environmental Health Program (EHP), which has responsibility for maintenance of HEPA-filtered ventilation systems and equipment. Provide guidance to EHP on appropriate decontamination of equipment prior to service.
Prepare, review, and communicate protocols and standard operating procedures (SOPs) for users of equipment designed and developed for specific research applications. Prepare and communicate protocols for decontaminating specialized biocontainment spaces.

A (4) Ensure Compliance
Possess knowledge of and familiarity with local, state and federal guidelines and regulations pertaining to research involving infectious and recombinant materials. Federal agencies involved include CDC, NIH, APHIS, EPA, FDA and WI Department of Commerce; state and local agencies include Dane County Division of Public Health, DATCP and DNR.
Participate in coordinating overall compliance for research involving select agents and toxins, and ensure compliance for biosafety aspects of this program, with the campus¿ Biosecurity Taskforce and federal agencies, particularly the Centers for Disease Control and Prevention (CDC) (42CFR Part 73) and the Animal & Plant Health Inspection Service (APHIS) (7 CFR Part 331 and 9 CFR Part 121). Serve the institution as an Alternative Responsible Official.
Maintain contact with the CDC Office of Health and Safety and the NIH Office of Biotechnology Activities concerning current requirements and recommendations for handling specific infectious and recombinant materials.
Assist researchers in obtaining the required permits (e.g. APHIS; CDC) for importing or shipping etiologic agents or regulated articles, and required licenses (e.g., Dept. of Commerce) for exporting controlled materials.
Assist investigators in complying with transportation requirements of the U.S. Department of Transportation and International Air Transportation Association for infectious substances and other regulated biological materials.

A (5) Conduct Laboratory Audits
Manage the program of periodic field audits to ensure that appropriate laboratory procedures are followed and facilities perform as expected. The BSO conducts lab audits that focus on the higher risk research activities, and directs OBS staff in conduct of others. These audits may be coordinated with other EH&S units, particularly regarding chemical and radiation safety, to improve overall efficiency for the department. Reports of findings are prepared to document each visit and are sent to the researchers. Follow up is done when significant deficiencies are noted to ensure corrective action. Records of these audits are maintained.
Investigate laboratory accidents involving research with infectious and recombinant materials. Root causes are identified, if possible, and changes are recommended in the facility and/or procedures to reduce likelihood of subsequent occurrence. Submit incident reports, as required, to local, state, and federal agencies. The IBC is informed and data regarding incidents is tracked.
Develop emergency plans for handling accidental spills and personnel contamination. Provide guidance and assistance with emergency decontamination.

A (6) Office Management
Work with the director in planning budget and project expenditures for the Office of Biological Safety.
Oversee record-keeping pertaining to work with infectious and recombinant materials. Maintain a confidential record of research protocol registrations to serve as the primary source of information on research-related biosafety issues.
Produce quarterly reports of OBS performance, produce an annual OBS performance report summarizing activities, progress towards, goals, and incorporate metrics showing specific progress in all key areas of OBS responsibility.
Share information with requesters including outside accrediting agencies (e.g. AAALAC, DOD), the IBC, other EH&S workgroups, researchers and administrators in biological sciences, FP&M Physical Plant supervisors, the University Health Service Environmental Health Program, and UW Police Department. Provide risk assessments, updated information, and mutual database access if appropriate. This function necessitates communication and cooperation with various professionals with diverse needs.

Additional Information:

Note: Employment will be contingent upon completion of satisfactory criminal background check.

TO ENSURE CONSIDERATION

Application must be received by: JULY 01, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #59146 to