Biosafety Program Manager & University Biosafety Officer
Location: Boston, Massachusetts
Internal Number: 3242494
Biosafety Program Manager & University Biosafety Officer
About the Opportunity
The Biosafety Program Manager & University Biosafety Officer (BPM) reports to the Associate Director of Education and Research Safety and is tasked with developing and executing all required components of a biosafety and biosecurity program to include establishing criteria for using infectious agents, select agents human materials, recombinant and synthetic nucleic acids and toxins, equipment, and processes in BSL -1 through BSL-3 settings. The BSM will establish and monitor safety and compliance objectives, directly engage Principal Investigators (PIs) to collaboratively manage biosafety/biosecurity requirements in a research laboratory setting, and actively investigate and promote continuous process improvement efforts at all levels of education and research safety. When asked, assume the day to day responsibilities of the Education and Research Safety Program in the prolonged absence of the Associate Director.
The BPM will possess excellent communication skills (verbal and written) and interpersonal skills to effectively promote biosafety concepts at all levels of the education and research enterprise including regularly engaging College Deans, Chairs, and Principal Investigators (PIs).
The BPM will serve as the university's subject matter expert regarding biosafety and biosecurity and must be self-motivated, technically skilled, and able to effectively influence biosafety and biosecurity performance, execute change, and promote collaborative problem solving. The BPM is responsible for the development and assessment of leading indicators and is instrumental in developing and implementing strategic plans to ensure continued biosafety/biosecurity improvement and program growth throughout all Northeastern laboratories
BPM responsibilities include the review of biosafety registrations, complex biological research protocols, and risk assessments and include making recommendations to the PI for improving safety and security associated with a specific project; working directly with the Associate Director to develop comprehensive and compliant biosafety and biosecurity training with a potential for providing hands-on biosafety training. Additional areas of responsibility include providing institutional oversight of Duel Use Research Of Concern (DURC), maintaining bio-use registrations with and providing regulatory reports to the City of Boston Public Health Commission and NIH; the development of biosafety and biosecurity resources; coordination of regulated medical and infectious waste management; oversight of the maintenance of records; directing staff to conduct autoclave audits, update biosafety/biosecurity manuals, Bloodborne Pathogens Exposure Control Plan, policies and procedures, auditing teaching and research laboratories, and assisting PIs with ensuring compliance with biosafety/biosecurity/biowaste management requirements in laboratories and storage areas located in research buildings. The BPM works in active collaboration with the Institutional Animal Care and Use Committee (IACUC), and provides training/support to academic departments, UHCS, and athletics. The BPM is an active and voting member of the Institutional Biosafety Committee and ensures that internal and external consultation is available to PIs for complex research projects using infectious materials.
The BPM will participate, as needed, with the Northeastern Emergency Response Team, and regularly be on-call outside of regular business hours to assist with the response to laboratory accidents involving biological material releases and will provide written evaluations of biological releases and accidents and be responsible for restocking supplies used in spill clean-up.
Bachelor's degree (Master's degree preferred) required in biology, molecular biology, microbiology, cellular biology, biochemistry, genetics, or related field.
Minimum of 9 years of demonstrated, hands-on experience working with biological agents in a research, teaching, diagnostic/clinical or quality control laboratory. Preferably, 6 years of work experience as a biosafety specialist at an academic or research institution.
Minimum of 5 years of demonstrated experience working in an EH&S office or similar compliance office with regular engagement with laboratory personnel as a part of a biosafety/biosecurity audit program with a minimum of 2 years of experience executing BSL-3 compliance requirements in a laboratory setting.
Comprehensive knowledge of applicable local, state, and federal regulations as well as NIH, USDA, NIAID, CDC guidelines for biosafety and biosecurity with demonstrated ability to evaluate complex biological research protocols using infectious agents.
Demonstrated knowledge of biosafety principles and best practices as well as federal, state, and local requirements for the use of biological materials and implementation of biosecurity components.
Strong interpersonal skills including the ability to communicate with a wide variety of personnel with a positive and helpful attitude.
Excellent communication skills and customer service skills and the ability to present information clearly and succinctly verbally and in writing. Ability to explain complicated technical concepts clearly and concisely. Ability to compile and present instructions as well as ability to clearly and concisely express ideas orally and in writing. Ability to effectively influence the safety behavior of teaching and research faculty, lab workers and other staff, and students engaged in high-risk activities. Capable of and comfortable with engaging PIs to ensure additional identified safety measures are included in all research protocols before start-up.
Ability to take initiative and think critically and creatively concerning individual situations and elements of the biosafety program with the ability to work independently and as a member of the team.
Proficiency in use of a personal computer and current software applications including but not limited to Microsoft Office Suite (Word, Access, Excel, PowerPoint, SharePoint, and Outlook). Proficiency in the use of data management software.
Demonstrated knowledge of common processes, equipment, and biological agent properties found in a laboratory setting. General awareness of process safety requirements in a research laboratory setting.
Experience with or ability to learn and utilize a Learning Management System (LMS) such as BlackBoard, Canvas, or other data management platform such as BioRaft, to implement safety training and other safety program management needs.
Be medically qualified to wear respiratory protection and other personal protective equipment as well as lift to 50 lbs. Work in a variety of physical environments where hazardous materials or equipment are in storage or use.
Required Credentials: Registered Biosafety Professional (RBP) or Certified Biological Safety Professional (CBSP).
Biosafety registration review, risk assessment and risk mitigation
- Review of biosafety registration documents and risk assessments for work with biohazardous materials.
- Review of standard operating or experimental procedures for work that involves biohazardous materials.
- Review of biosecurity components developed and implemented for each laboratory.
- Responsible for the maintenance of records and documentation including training records, safety equipment certifications, hazard surveillance reports, biosafety registrations and amendments, approval letters, biosafety manuals and exposure control plans.
- Interact with members of the scientific community and participate as a voting member of Institutional Biosafety Committee meetings.
- Act as the subject matter expert for university leadership and research faculty regarding safe practices to be utilized in teaching and research settings involving biological materials. - Commissioning and decommissioning of laboratories using biological materials.
- Stay informed of regulatory changes impacting biological research and ensure regulatory changes are incorporated into safety programs and training.
- Actively participate in the design and construction of biological research labs and facilities. Attend laboratory pre-construction meetings and project meetings to communicate performance expectations for biosafety laboratories. Reviews laboratory construction project design documents and specifications. Provides comments and recommendations with respect to compliance with Office of Education and Research Safety (OERS) guidelines for design.
- Establish and maintain relationships with internal and external subject matter experts for collaborative review of unique and complicated research protocols as needed.
Leadership and Supervision
- Hire, evaluate performance, guide performance improvement, and contribute to the profession growth of Biosafety Specialists and the success of the Biosafety Program.
Audits and Consultation:
- Reinforce the use of appropriate procedures, controls, regulations and policies regarding safe laboratory practices, activities, equipment and environmental conditions that might have an impact on reducing laboratory associated infections from the use of biohazardous materials.
- Supervise the audit of laboratories using registered biohazardous materials, review the audit findings' reports, and the effective correction of identified deficiencies.
- Compile data and develop reports related to biosafety and other environmental health and safety information/trends and regularly submit reports to the Associate Director and AVPERS.
- Ensure the compliant maintenance of records and documentation including training records, hazard surveillance reports, lab inspection reports, security inspections, and other regulatory compliance documents.
- Recommend and assist with conducting exposure assessments in laboratories and other work environments where biological agents are used.
Regulated Medical and Infectious Waste Management
- Oversee regulated waste disposal vendors with a focus on timely pickup of waste.
- Ensure the maintenance of biowaste records and documentation including biowaste training records, waste manifests, autoclave logs, and spore testing results.
- Assist other OERS professional staff with outreach, projects and emergency response actions to mitigate spills or releases of biological agents as needed.
- Support the campus-wide lab coat program.
- Assist with the University's safety observation program.
- Participate in incident investigations, accident causation analysis, and the documentation and execution of corrective actions.
- Assist program managers with indoor air quality and industrial hygiene assessments including air and/or surface testing
- Provide biosafety training as needed to various groups within and outside of the organization. - Assist with efforts of program managers in the use of platforms and modules associated with the compliance management system.
- Other laboratory safety duties as assigned by the Associate Director or their delegate.
Legal and Regulatory Administration
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.