Job Title:
Biocontainment Hazards Officer

Company: St. Jude Children's Research Hospital

Location: Memphis, TN

Created: 2024-05-14

Job Type: Full Time

Job Description:

St. Jude's Environmental Health and Safety is looking for a Biocontainment Hazards Officer to manage special hazards in support of the institution's research and clinical programs' mission to find cures and save children. This role is responsible for planning, coordinating, and directing the regulatory and safety operations related to research use of highly hazardous pathogens and biological toxins, Select Agents, and other specific hazards identified by St. Jude or Environmental Health and Safety (EHS) leadership. Serving as a specialist in laboratory and animal biosafety that supports the institution's select agent and other special hazards regulatory compliance is also a key responsibility. At the direction of the EHS Director, the Biocontainment Hazards Officer also ensures regulatory compliance (for example, Select Agent regulations, National Institutes of Health recombinant guidelines, DOT regulations, Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines, Department of and Commerce Export regulations) pertinent to highly hazardous biological agents. It is vital that this person supports the investigators and research programs that are subject to these regulations. The position challenges the holder to integrate a broad knowledge on topics including regulatory compliance, laboratory management and research support for special hazards.Whether you have a strong background in this type of role, or you are looking to transition from research into more of a steady and compliance-focused environment, we encourage you to explore this unique and important opportunity with St. Jude today!Minimum Education and/or Training:A Master's degree is required. A PhD will be accepted with appropriate experienceMinimum Experience:If Master's degree, two (2) years of experience in biomedical regulatory compliance and/or biocontainment research is required.If PhD, two (2) years of postdoctoral biomedical research and/or biocontainment research experience will be considered.Job Responsibilities:Addresses Regulatory Compliance Issues in Biosafety Laboratory Level 3 - Enhanced Facilities: With oversight of the Responsible Official (RO), manages compliance with the Select Agent regulations. Serves as an Alternate RO. Manages, facilitates and reviews transfers of all Select Agents in use or storage in the biocontainment facilities to ensure compliance with dangerous goods shipping and Select Agent related regulationsDevelops and implements Select Agent-related policies and procedures. Works with RO; Biosafety Officer (BSO); GMP, LLC staff and Animal Resource Center (ARC) Director to develop policies and procedures for compliance with applicable safety guidelines and animal welfare regulations. Assists St. Jude staff including the ARC Director and RO in the development and preparation of standard operating procedures for security, incident response and biosafety.Coordinates and conducts regular programmatic reviews and inspections of the Biosafety Level 3 enhanced (laboratory and animal) facilities registered to use and store Select Agents. Reviews include using standardized inspection criteria required for regulatory compliance that are based on Select Agent, Animal Care and Use Committee and animal welfare regulations. Conducts risk assessments, drills, and annual reviews to support the RO; BSO; the GMP, LLC staff and ARC Director.Reviews animal care and use protocols and IBC proposals related to the Biosafety Laboratory Level 3 enhanced (laboratory and animal) facility using Select Agents to ensure compliance with committee guidance. Manages, coordinates and documents operations of the Select Agent programOversees periodic review of standard operating procedures, data analytics, and select agent and animal inventoriesMaintains computer databases and issues reports on authorized users of the relevant biocontainment facility in coordination with the EH&S staff. Performs periodic containment security analysisIn collaboration with the RO; GMP, LLC staff and ARC Director; manages, coordinates and documents physical operations of Biosafety Laboratory Level 3 Facilities. Coordinates annual facility certifications (decontamination, test and balance of heating, ventilation and air conditioning, equipment certifications) to comply with the regulations. Coordinates facility maintenance and repairs with GMP, LLC staff; ARC; FOM and D&C departments.Ensures all authorized users have completed all requirements to gain and maintain access to the Biosafety Laboratory Level 3 - enhanced facilities using or storing Select AgentsPrepares and edits memoranda, emails or letters for distribution to research personnel, institutional administration and animal husbandry personnel concerning special hazards regulatory topicsResponds to problems and alarms immediately (24 hours a day, 7 days a week)Works with EHS safety officers and others to perform hazard and risk assessments, incident and near miss investigations and inspectionsMaintains electronic and paper records concerning all aspects of special hazard work on campusCompiles and reports on information required by regulatory agencies such as the USDA, the DEA, OSHA, The Joint Commission, or the Office of Laboratory Animal Welfare from information maintained by Special Hazards OfficerManages, coordinates and documents all training and access requirements related to specific hazards. Prepares and presents educational materials to appropriate St. Jude staff to comply with specific hazard standards. Provides training concerning special hazards to St. Jude staff. Conducts knowledge, competency and proficiency evaluations of personnel regarding relevant policies and procedures.Assists in maintaining the records associated with training and other mitigation measures in place for special hazards on campusServes on the appropriate committees (to include the Safety Committee, Institutional Biosafety Committee [IBC] and Animal Care and Use Committee [ACUC]) and/or reviews proposals for approval on special hazards for the committees. Reviews animal protocols and IBC project applications submitted by research investigators for compliance with guidelines and regulationsDevelops and implements similar management programs for other specific hazards identified or brought to campus as directed by St. Jude leadershipPerforms other related duties as assigned or directed to meet the goals and objectives of the department and the institutionMaintains regular and predictable attendanceCompensationIn recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $94,640 - $169,520 per year for the role of Biocontainment Hazards Officer.Explore our exceptional benefits!Diversity, Equity and Inclusion St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world"ā€¯regardless of race, religion or a family's ability to pay. Learn more about our history and commitment.Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.St. Jude is an Equal Opportunity EmployerNo Search FirmsSt. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.