Minimum Education and/or Training:

• A Master's degree is required. A PhD will be accepted with appropriate experience

Minimum 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 regulations
• Develops 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 program
• Oversees periodic review of standard operating procedures, data analytics, and select agent and animal inventories
• Maintains computer databases and issues reports on authorized users of the relevant biocontainment facility in coordination with the EH&S staff. Performs periodic containment security analysis
• In 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 Agents
• Prepares and edits memoranda, emails or letters for distribution to research personnel, institutional administration and animal husbandry personnel concerning special hazards regulatory topics
• Responds 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 inspections
• Maintains electronic and paper records concerning all aspects of special hazard work on campus
• Compiles 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 Officer
• Manages, 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 campus
• Serves 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 regulations
• Develops and implements similar management programs for other specific hazards identified or brought to campus as directed by St. Jude leadership
• Performs other related duties as assigned or directed to meet the goals and objectives of the department and the institution
• Maintains regular and predictable attendance

Compensation

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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-regardless of race, religion or a family's ability to pay. .

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 to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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