Biological Safety Officer
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
Job Description Summary
The Biological Safety Officer is responsible for the Biosafety Program at STEMCELL and ensures that all laboratory facilities are in compliance with the Human Pathogens and Toxins Act (HPTA) and Regulations (HPTR) and with the applicable biosafety and biosecurity standards. Reporting to the Director, Environmental, Health and Safety (EHS), this role provides oversight of biosafety and biosecurity practices within STEMCELL, including the overall management, administration and continual improvements of the biosafety program.
Specific responsibilities include developing policies, monitoring compliance, conducting risk assessments and internal inspections/audits, documenting and updating biosafety-related training, assisting in investigations of incidents, compiling and providing any reports/documentation as required by regulatory agencies, and liaising with containment zone personnel, support staff, housekeeping personnel, and contractors on biosafety-related matters. This role leads the cross-functional Pathogen Safety team as well as reviewing and approving all PHSA and CFIA applications for license and permit.
Duties and Responsibilities
- Review and approve all internal biosafety applications prior to submission to regulatory bodies.
- Lead, manage and administer the Biosafety program across the organization, promoting safe practices and procedures in biological safety and research.
- Audit and enhance the medical surveillance program as appropriate.
- Coordinate the development, review, evaluation, implementation, promotion, maintenance and training/education of biosafety and biosecurity policies and practices company-wide globally.
- Ensure all laboratory facilities comply with the HPTA/HPTR compliant biosafety/security manual that is relevant, up-to-date, and compliant with all Act and Regulation requirements. Assist in the development, implementation and maintenance of the manual.
- Contribute in the development and coordination of a biosafety/biosecurity training/education program, including transport of dangerous goods, personal protective equipment, waste management and facility management.
- Recommend implementation of corrective actions / processes / procedures in biosafety/biosecurity.
- Develop protocols for, and conduct regular inspections and biosafety/biosecurity audits evaluating compliance with all legislation; report on the findings to senior management.
- Provide subject matter expertise, and consult with appropriate clinical areas within the Operations and Research departments, including principal investigators regarding the identification, evaluation, and mitigation of biological hazards and maintaining compliance with appropriate legislation.
- Co-chair and manage the agenda of the Biosafety Committee and participate in other appropriate committees across the organization that pertain to biosafety/biosecurity matters.
- Perform all investigations, communications and assist with internal investigations of incidents described in the HPTA/HPTR.
- Complete PHAC (Public Health Agency of Canada) and CFIA (Canadian Food Inspection Agency) licence/permit applications.
- Perform all administration related to the HPTA/HPTR including but not limited to: liaising with the licence holder(s) and the PHAC/Minister, preparing and submitting licence permit applications.
- Completes incident reports (inadvertent possession of positively identified pathogen etc.) and uploads report to PHAC Biosafety portal.
- Work with the Pathogen Safety Team SOs from other labs (internal and external) to ensure seamless and safe movement of isolates between organizations. Work with other labs on joint biosafety efforts that affect the organization’s biosafety and security.
- Performs other related duties as required.
- Accept the professional and ethical responsibility to protect privacy, use confidential information appropriately, and maintain the confidentiality and security of all information related to staff.
- MLT or Bachelor’s, MSc or PhD in Microbiology or other advanced training in microbiology or biosafety/biosecurity.
- Completion of or working towards a professional designation such as Registered Biological Safety Professional (RBP) or Certified Biological Safety Professional (CBSP) is an asset.
- Minimum 5+e years of related work experience in compliance, regulatory affairs or other related field leading a biosafety/biosecurity program
- Knowledge of microbiology appropriate to the risks associated with the controlled activities authorized by the organization’s licence, attained through a combination of education, training and experience.
- Knowledge of principles and practices pertaining to Biosafety and Environmental Health and Safety in general.
- Knowledge of the provisions of the Human Pathogens and Toxins Act, its regulations and any applicable legislation.
- Experience with developing biosafety/biosecurity programs, including related policies, processes, and training/education.
- Demonstrate leadership through change and promote change initiatives.
- Ability to identify problems, apply sound judgement, and proactively take the initiative to address issues.
- Strong interpersonal and communication skills (oral and written). Ability to build positive working relationships and work effectively and collaboratively in a team environment.
- Consistently seeks to ensure that professional conduct and personal behaviours broadly align with STEMCELL’s values.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
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