As a BSL3/ABSL3 Manager, you will manage a High Containment Laboratory and will provide administrative and biosafety support and direct oversight of biosafety policies and procedures for the BSL3/ABSL3 facility. As a BSL3/ABSL3 Manager, you will manage implementation and maintenance of designated programs. Plans, develops and maintains systems and procedures. Acts as a liaison between department and outside communities. Serves as a coach and mentor for other positions in the department. Participates in budgetary process.
Cleveland Clinic provides what matters most: career growth, delivering world-class care to our patients, continuous learning, exceptional benefits and working for an organization that offers many long-term career paths. Join us and experience a culture where opportunities to advance and the support to get there go hand-in-hand.
- Develops, implements, manages and maintains operational systems and activities.
- Serves as a liaison with all levels of the organization and outside community.
- Manages multiple priorities and projects with competing deadlines.
- Allocates time to meet completion requirements.
- Serves as a coach and mentor for other positions in the department.
- Reviews and monitors adherence to Human Resources policies and corporate compliance procedures.
- Other duties as assigned.
- Bachelor’s degree in Business Administration, Healthcare Administration or related field.
- Master’s degree preferred.
- May be required for specific positions as per policy or regulation.
Complexity of Work:
- Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
- Must be able to take appropriate action in a stressful environment.
- Demonstrated team, leadership, organizational, financial management and problem solving skills.
- Knowledge of statistical and financial analysis, primary research and business plan development.
- Strong presentation, communication and training skills required for most positions.
- Minimum of five years of related experience; healthcare setting preferred.
- Offset: Master’s degree and four years of experience.
Key Job Responsibilities:
- Provides safety and compliance oversight of research in BSL3/ABSL3 and other containment facilities
- Provides biosafety expertise in support of design, commissioning, performance verification, maintenance and annual verification
- Develops, implements, and performs periodic or annual updates to safety, security, and standard operating procedures (SOPs)
- Develops and provides containment training courses for researchers working with BSL3/ABSL3, in collaboration with Biosafety Officers (BSO)
- Conducts and documents biosafety, biosecurity, inventory related inspections for containment and other biohazard areas as needed.
- Coordinates and documents validation of maintenance and regulatory compliance requirements on equipment, the facility, and select agents
- Ensures that the facility and the practices within the facility are in compliance with all federal, state, and local regulations
- Liaisons with regulatory agencies particularly during testing, commissioning, performance verification, audits, inspections, i.e. Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), National Institute of Health (NIH), Federal Bureau of Investigation’s Criminal Justice Information Services (CJIS), and Division of Select Agents and Toxins (DSAT)
- Maintains safe day-to-day operations and works closely with Research Leaders/PIs, Environmental Health and Safety (EHS), Facilities Management and/or external vendors and monitors compliance, maintenance and repairs, and coordinates research activities and resource scheduling
- Manages the clearance and access program with key partners (i.e. Protective Services, Occupational Health Screen, etc.) and coordinates training for new users
- Sources and maintains an inventory of required safety supplies and laboratory equipment to ensure full compliance with SOPs and to meet end user research needs
- Coordinates laboratory and equipment decontamination and maintenance with EHS and external vendors
- Provides expert advice regarding the safe and compliant acquisition, use, management, storage, and disposal of hazardous materials
- Works closely with the Institutional Biosafety Committee (IBC), Biological Resources Unit (BRU) and Institutional Animal Care and Use Committee (IACUC) and assist in reviewing protocol registrations when needed
- Serves as an Alternate Responsible Official and assists the BSO/RO in overseeing the Select Agent Program
- Helps coordinate and participates in proper emergency response procedures and serves as a member of the BSL3 /ABSL3 Emergency Response Team
- Coordinates and provides training for local first responders
- Executes and documents drills and exercises to evaluate the efficacy of the security plan, biosafety plan and incident response plan
- Assists with transfers of high-risk biohazards
- Provides routine communication with stakeholders
- Participates in cost model development, use projections and budgeting
- Other duties as assigned.
Preferred Qualifications, Education, & Experience:
- MS or PhD degree in Biological Sciences
- Biosafety professional credentials
- Experience working on or with institutional compliance programs and committees (e.g. Institutional Biosafety Committee, Institutional Animal Care and Use Committee, Institutional Review Board)
- Experience working in an animal research facility
- Familiarity with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), select agent regulations, Biosafety in Microbiological and Biomedical Laboratories (BMBL), import and export programs (e.g. CDC IPP, APHIS, Bureau of Industry and Security), OSHA, and other regulations or guidance documents relevant to Biological safety
- Demonstrated understanding of a regulatory environment and ability to interpret regulations and institutional policy
- Demonstrated ability to manage confidential information, work independently and exercise good judgment
- Strong organizational and time management skills to deal with heavy work volume and deadlines
- Strong interpersonal skills and demonstrated ability to work with many levels within the organization
- Computer experience in maintaining and working in databases, email systems and websites
- Bachelor’s degree, preferably in biological sciences and five years of work experience in research compliance, research administration or BSL3/ABSL3 research environment or related experience or an equivalent combination of education, training and experience
- Proficient in technical writing and safety training development and delivery
- Working knowledge of Select Agent regulations (CFR 42/Chapter I/Subchapter F/ Part 73)
- Excellent verbal and written communication skills
- Willing to work in, and with personnel who work in, a high containment laboratory that contains hazardous biological agents and animals potentially infected with hazardous biological agents
- Ability to communicate and exchange accurate information.
- Ability to perform work in a stationary position for extended periods.
- Ability to work with physical records or operate a computer or other office equipment.
- In some locations, ability to travel throughout the hospital system.
- In some locations ability to move up to 25 lbs.
Personal Protective Equipment:
- Follows Standard Precautions using personal protective equipment as required for procedures.
Apply for the BSL3/ABSL3 Research Facility Program Manager III