Biosafety Program Manager

Role Overview:

Reporting to the Mass General Brigham Senior Director of Biosafety, this individual maintains the integrity of the MGB Biosafety and Export Controls Compliance Programs. This includes being the administrator for the Institutional Biosafety Committee (IBC), Dual Use Research Review Committee (DRC), Biosafety Program, and related working groups. In addition, they identify and manage projects, such as improving the Insight Biosafety module, managing educational programs, overseeing content and implementing postings on the Internal Websites related to biosafety and the IBC; and assisting in policy and SOP development, implementation, and obtaining approvals by senior management. This individual is responsible for developing and maintaining biosafety compliance databases and files to support these operations, and performs other duties as requested by the Sr. Director of Biosafety. Finally, they will be responsible for effective communication, continuity, and compliance with federal, state, and local environmental health and safety regulations as well as compliance requirements for biosafety (NIH OBA, CDC/APHIS, and other sponsoring agency requirements) across the MGB enterprise.

Principal Duties and Responsibilities:

• Uses Mass General Brigham values to govern decisions, actions, and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.

• Establishes procedures, plans, databases, and filing systems to ensure appropriate compliance record-keeping and smooth operation of the office.

• Capable of learning and using computer databases and systems managed by Mass General Brigham (i.e., Insight, Healthstream, Peoplesoft, etc.) and external entities (i.e., NIH Registration Management System, DFCI IRIS, etc.)

• Manages administrative responsibilities for the IBC including logistical arrangements for monthly, ad hoc, and subcommittee meetings, drafts meeting minutes, assists in the identification of new committee members, and coordinates scientific reviews of registrations by scientific committee members.

• Tracks and verifies compliance status of biosafety registrations in Insight; reviews and approves administrative transactions and triages biosafety workflows to identify scientific transactions requiring full-committee review or Senior Director of Biosafety approval. Prepares reviews of low-risk scientific amendments for Senior Director of Biosafety approval.

• Manages the MGB Biosafety Training and Education Programs offered by the IBC Office by developing compliance plans and initiating/assisting in the development, review of materials, distribution/execution of annual, ad hoc, and Biosafety trainings, and escalation of non-compliance.

• Manages the MGB Biosafety Communications Program by identifying topics relevant to investigators with biosafety protocols such as upcoming modifications to the eIBC and any regulatory and MGB policy updates, training requirements, resources and guidance, and those requested by the institutional biosafety officers and Senior Director of Biosafety. Responsible for writing communications and distributing them to relevant parties and on the Research Navigator.

• Works with Mass General Brigham Research Applications on Insight eIBC system maintenance, functionality, upgrades, user audits, and all other activities necessary to maintain IBC data and smooth operations of IBC activities.

• Responsible for submitting, and collecting required materials for, annual reports to the NIH and Cities of Boston, Cambridge, and Belmont. Initiates and ensures payment for annual laboratory permits.

• Serves as IBC representative on Research Compliance Committees and hospital research events.

• Responsible for the internal IBC research compliance website and serves as representative on the Communication Steering Committees.

• Responsible for drafting and updating content and identifying new content for IBC sites.

• Works with other research compliance content owners to keep content current through audits & reviews.

• Performs other duties as may be assigned by the Senior Director of Biosafety.

Qualifications:

• Bachelor's Degree required. A Master's Degree in a relevant discipline (e.g., life sciences, allied health fields, or safety fields) is preferred.

• One to two years of microbiological laboratory, biosafety, and/or research compliance experience is required.

• Knowledge of Microsoft applications is required.

Skills/Abilities/Competencies:

• Possesses strong interpersonal skills to effectively communicate, negotiate, and collaborate with cross functional teams such as Research Leadership, PIs, and staff of different skill sets and backgrounds at all levels within and external to MGB.

• Proficient in using computer software applications such as Microsoft Excel, Word, PowerPoint and Adobe.

• Excellent oral and written communication skills and the ability to effectively conduct meetings, both formal and informal. Must be poised and self-possessed when speaking in front of groups, representing the office, and interacting with faculty one-on-one and in small groups.

• Strong customer service orientation. Must be able to assess customer's needs and provide solutions.

• Requires minimal direction from leadership and possesses strong ability to learn quickly, analyze, and problem solve.

• Ability to work independently with minimal supervision and with integrity.

• Must be able to manage multiple responsibilities often under time pressures.

• Strong attention to detail as well as ability to accurately prioritize workflows.

Supervisory Responsibilities:

• May provide leadership and guidance to new staff.

Working Conditions:

• Work is performed in a hybrid, in-person, and remote office environment.

• Normal office working conditions when in-person. The noise level in the work environment is quiet.

• Local travel to MGB member institutions for monthly IBC meetings, as well as other system-wide meetings and training sessions requiring some travel.

About Us:

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.

We're focused on a people-first culture for our system's patients and our professional family. That's why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees' personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development-and we recognize success at every step.

Our employees use the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.