Associate Director, Biosafety

Associate Director, Biosafety

General Summary

This position is responsible for leading the Southern Research biological safety program. The Associate Director of Biosafety (ADB) serves as the Biosafety Officer (BSO) and Select Agent Responsible Official. The ADB ensures the biological safety program is compliant with all applicable federal, state and local environmental, health, and safety regulations as per NIH/OSP, CDC, APHIS, OSHA, DOT and other regulatory agencies. The ADB provides guidance in all matters considered to be of a biosafety nature including regulation interpretation, biological containment, biosafety and biosecurity practices, risk assessment and medical surveillance/occupational health considerations. The ADB serves as the Responsible Official (RO) having the authority and responsibility to act on behalf of the entity to ensure compliance with the United States Select Agent Regulations. While the RO can delegate duties to others to achieve efficiencies in oversight; the RO retains responsibility to ensure that the registered entity is in full compliance with the select agent regulations.

 Key Responsibilities

• Works closely with Senior Leadership, the Director of EHS and EHS personnel to develop, improve and oversee SR-wide Safety and Environmental processes.
• Administrative oversight of the Biosafety and Select Agent Programs for the entity.
• Supervises members of the EHS group.
• Must have authority and responsibility to act on behalf of the entity regarding the select agent and biosafety programs.
• Develops and implements biosafety, biosecurity, incident response, and personnel suitability plans in accordance with CDC/USDA Select Agent regulations, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), and industry best practices.
• Develop and implement training and exercises to ensure all staff working with biological hazards are properly prepared to safely perform their roles.

Position Specific

• Must be approved by the HHS Secretary or Administrator following a security risk assessment by the Attorney General.
• Must be familiar with and ensure compliance with requirements of the Select Agent Program as stated in 42 CFR Part 73 (HHS-CDC), 9 CFR Part 121; 7 CFR Part 331 (USDA-APHIS).
• Oversee all aspects of the select agent program.
• Maintain frequent communications with Principle Investigators, scientists and laboratory personnel to ensure laboratory operations are safe, meet regulatory expectations, and are scientifically sound.
• Ensures the entity's Select Agent Form 1 registration is up to date and acquires CDC/APHIS approval prior to implementing proposed changes.
• Ensures annual review 
• Available to travel occasionally to attend conferences and/or training
• Testing of above-mentioned plans, in the form of drills and/or tabletop exercises. Plans will be updated at this time, after an incident, or more frequently as needed.
• Respond to and investigate biologically hazardous incidents.
• Interact directly with CDC, Department of Agriculture, NIH and other regulatory officials.
• Maintains detailed records of information necessary to provide a complete accounting of all activities related to select agents or toxins use, or transfer.
• Reports to CDC the identification of a select agent or toxin as a result of diagnosis, verification or proficiency testing in accordance with the regulations.
• Serve on the Institutional Biosafety Committee and other committees/working groups as appropriate to the role.

Minimum Qualifications

• Degree in a life sciences discipline
• Minimum of seven years' experience working in high biological containment environments
• Minimum of five years' experience in biosafety
• Experience performing risk assessments and developing mitigation plans
• Excellent interpersonal and verbal/written communication skills
• Knowledge of Code of Federal Regulations (OSHA, EPA, etc.) to ensure facility compliance with all federal and state agencies
• Knowledge of use of protective equipment and safety protocols associated with the handling of hazardous materials
• Willing and able to be on call 24x7 and able to work on weekends and/or holidays if necessary to respond to emergency situations
• Demonstrated ability to utilize a variety of computer programs including Microsoft Office Suite and/or other database tools

Preferred Qualifications

• Advanced degree in a life sciences discipline
• Experience as a Responsible Official or Alternate Responsible Official
• Knowledge of high containment lab design and HVAC equipment
• Understanding of IBC, IACUC protocols
• Knowledge of hazardous waste material management
• Knowledge of the use of PPE and safety protocols closely associated with work performed in high containment environments
• Trained in Bloodborne Pathogen and Hazard Communication Standards

Preferred Certifications, Licenses & Registrations

• Registered Biosafety Professional or Certified Biological Safety Professional

Work Environment & Conditions

This position is required to work in both the office and laboratory setting.  Entry to biosafety laboratory and animal research environments will require use of PPE, vaccinations, and medical clearance. This position requires approval to be enrolled in the A/BSL-3 program, the personnel suitability program, and other associated programs that are in place or may be developed during the tenure in this job.  These environments have unique demands and must be met to fulfill job requirements.

Physical Demands

• Ability to climb ladders and stairs in performing work
• Ability to walk for considerable distances in performing work
• Ability to lift objects frequently in performing work
• Ability to pull or push objects on a regular basis
• Ability to reach for object above head or below waist
• Ability to stoop or crouch by bending at the waist or by bending legs
• Ability to perform work utilizing a computer for extended periods of time
• Ability to sit or stand for extended periods of time