Associate Director, Biosafety
- Southern Research
- Birmingham, AL
- Start date
- Jan 22, 2023
- Manufacturing & Production, Facilities & Site, Safety, Regulatory, Legal/Compliance, Regulatory Affairs, Science/R&D, Biology
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
Associate Director, Biosafety
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.
- 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.
- 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.
- 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
- 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.
- 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
MOVING SCIENCE. Our experts turn what couldn't be done into what we can't live without. By translating research into innovation, we act as catalysts that save lives and cultivate Birmingham's biotech scene. We are conduits between Science and Society. With precision, we transform ideas into discoveries. We see possibilities before they exist and activate scientific progress that is purposeful. We move science, because the promise of a brighter future moves us. We work with more than 150 industry and academic partners to drive scientific discoveries. From drug discovery to development, to carbon capture and environmental health sciences, every layer of our scientific and professional teams serve a fundamental role in moving science. We're making Birmingham the biotech hub of the southeast. Coming in 2024, our new biotech center will feature 60,000 sq. ft. of commercial wet labs, A/BSL-3 space and data science facilities. Our team will grow 125 scientific jobs and help shape the future of biotech in Alabama. We're investing in renovations of 40,000 sq. ft. of facilities including vivarium space and launching a new clinical diagnostics lab.
- (205) 581-2000
2000 9th Avenue South
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