The Biosafety Officer discharges duties of ensuring safety to workers in biological research, patients, visitors, and environment. The Biosafety Officer oversees the Laboratory Safety program and ensures safe and compliant practices. The Biosafety Officer works with stakeholders throughout the Institute to advance biosafety elements and collaborate with federal, state, and local government regulatory agencies, to keep up to date.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Ensures compliance with the requirements of the Biosafety in Microbiological and Biomedical Laboratories and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the OSHA Bloodborne Pathogen Standard, the CDC-NIH Biosafety in Microbiological and Biomedical Laboratories.
• Manages compliance with NIH granting agency directives on transparency of BCC review, and the review of grants for DURC and ePPP directives, and updates policies in Euclid as required.
• Accepts responsibility for management of the biosafety review of clinical trials at every stage. This requires:

1. Screening SRC agenda for clinical trials involving human gene therapy or infectious agent that proposals require IBC review, in the event that the study team did not correctly answer question 11.2, which routes the trial to biosafety. Reporting errors to OHRS and Study Team.
2. Assigns scientific reviewers of clinical trials, obtains additional information from sponsors as required by reviewers, and maintains detailed files to allow administrative approvals, when appropriate, based on precedent reviews and verification by a scientific member.
3. Writes approval or deferral letters and completes all iRIS-related documentation.
4. Provides, in Healthstream, a training course for clinical research coordinators that is adapted to their role: Bloodborne Pathogen Training, IATA and DOT training for shipping clinical trial specimens, and UPS800 training related to the task of counting pills returned by clinical trial participants,

• Performs risk assessment for every laboratory registration and amendment in iRIS-IBC for presentation to the BCC.
• Administratively approves projects as appropriate, with validation of the risk assessment at the next DFCI Biohazard Control Committee.
• Prepares IBC minutes for each BCC meeting, and, after approval, submits the minutes to the public-facing DFCI online.
• Does lab procedure audit for toxin or infectious agent projects.
• Prepares the BL2 permit submission for the Boston Public Health Commission, and the BL3 permit, if required.
• Reviews and updates and promotes biosafety programs in compliance with the various published laws, regulatory agencies and standards impacting biological safety and biosecurity.
• Does biosafety risk assessment for international shipments to high-risk countries for the Compliance Office. Assists researchers by interpreting international shipping documentation requirements, harmonized code assistance for shipping internationally, export control requirements,   CDC and USDA Import Permit submission assistance.
• Writes and delivers, or assigns delivery, of Research and Clinical Laboratory safety orientation/ training for newly hired laboratory research and clinical employees. Provides Lentiviral vector orientation in Healthsteam and research Lab safety refresher training. In person training is provided for LN2 handling, shipping biological materials, Lab Safety refresher courses to existing employees or any other training required.
• Inspects Regulated Medical Waste rooms in both main campus and satellites.
• Conducts annual or semiannual biological safety audits for research laboratories. Reports results to the BCC, Lab Safety Committee. Adjusts biosafety training to nip trends in non-compliance.
• Evaluates use of Personal Protective Equipment in laboratory procedures
• Coordinates the reusable sharps container program to assure timely waste pick-ups and delivery of this essential tool.
• Responds to and coordinates emergency response for biohazard spills and taking on-call duties for biosafety emergencies.
• As a voting member of the IACUC, reviews every protocol and votes on whether full committee, or designated member review, is appropriate.
• Assists researchers and collaborating units (e.g., OHRS, IC, IACUC) with developing and writing hazard safety protocols and with establishing and implementing research program specific processes and controls related to their work and experimentation with hazardous materials or techniques.
• Conducting Root cause Investigations associated with laboratory accidents or incidents and near misses in collaboration with Occupational Health Services.
• Oversees the certification, troubleshooting, and repair of 720 biosafety cabinets.
• Participates in periodic IACUC program reviews, facilities inspections, and monthly committee meetings.
• Memberships of various safety committees (e.g., Blood Borne Pathogens, Institutional Animal Care & Use Committee, Laboratory Safety Committee, Institutional Safety Committee etc.)
• Updates the OSHA Bloodborne Pathogen Control Plan for Research annually.
• Develops collaborative atmosphere that supports the safety culture.
• Participate in training programs such as ABSA conferences, online training, participating in scientific programs and actively pursue professional development
• Performs other related duties as requested by the reporting director.

• Bachelor?s degree in biology, Biotechnology, Occupational Health, Environmental Sciences, or related field required.
• Master?s degree or Doctorate (plus 1 year experience) in a relevant Scientific Discipline preferred.
• Five (5) years directly related professional experience in a biological safety program in a research environment including active laboratory experience in microbiology and/or molecular biology involving viruses of eukaryotes, cell culture, bacterial culture, toxins and/or work with infectious materials.
• Two (2) years experience in managing laboratory safety programs preferred.
• Experience with Laboratory procedures and animal model studies required.
• Biosafety certifications (e.g., Registered Biosafety Professional or Certified Biological Safety Professional) or planning to complete biosafety certification soon preferred.
  

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Strong written and verbal communication skills with the ability to influence key stakeholders.
• Ability to be self-motivating, flexible and adaptable in an environment with competing priorities.
• Ability to motivate high performance, promote culture of safety, manage change, and resolve conflicts.
• Ability to evaluate worksites for potential hazards, conduct necessary monitoring, write reports and relay information to all levels of DFCI staff.
• Ability to determine biological characteristics of the waste handled and direct segregation for transportation to waste processing plants.
• Understanding regulations and agency guidelines such as National Institutes of Health, Centers for Disease Control and Prevention, Occupational Safety & Health Agency, Environmental Protection Agency, Department of Transport, International Air Transit Association, Massachusetts Department of Environmental Protection, Boston Public Health Commission, and Boston Fire Department Standards. and implementation of compliance programs.
  

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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