Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

Reference Number: R2852350

Department:Biosafety Officer

Location: Toronto, ON

About the job

The Biosafety Officer (BSO) oversees biosafety and biosecurity practices, ensuring compliance with the Canadian Human Pathogen and Toxins Act (HPTA) and its Regulations (HPTR), and Sanofi Biosafety standard, acts as the primary contact with the Public Health Agency of Canada (PHAC), and manages risks associated with all activities involving biohazardous materials, including in laboratory and manufacturing.

Summary Of Purpose:

The Biosafety Officer (BSO) oversees biosafety and biosecurity practices, ensuring compliance with the Canadian Human Pathogen and Toxins Act (HPTA) and its Regulations (HPTR), and Sanofi Biosafety standard, acts as the primary contact with the Public Health Agency of Canada (PHAC), and manages risks associated with all activities involving biohazardous materials, including in laboratory and manufacturing.

About Sanofi 

We’rean R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main Responsibilities:

Promote and monitor compliance to HPTR through

• Managing the Biosafety and Biosecurity program on site

• Leading the biosafety and biosecurity risk assessments

• Advising on biosafety and biosecurity technical matters, in accordance with the HPTA and its regulations (HPTR), the Canadian Biosafety Standard (CBS), and Sanofi Biosafety global standard.

• Developing and providing training related to biosafety and biosecurity policies, standards, and practices.

• Conducting periodic internal inspections and biosafety audits and reporting findings to the licence holder representative (LHR) and site HSE leadership team.

• Informing the LHR in writing of any non-compliance by a person conducting activities under the licence that is not corrected after that individual has been made aware of it

• Assisting in the development and maintenance of the biosafety manual and standard operating procedures (SOPs) related to biosafety and biosecurity

• Assisting with internal investigations of biosafety and biosecurity related incidents

• Chair and maintain the site Biosafety and Biosecurity Committee, ensuring documented meeting minutes are created.

Under the PHAC licence, the BSO will

• Possess a valid Biosecurity Portal Account and never transfer or share the access code or the account with another individual or employee.

• Maintain and update, as required, the Pathogen and Toxin Licence (PTL) via the Biosecurity Portal in collaboration with the LHR.

• Designate an ABC, if necessary.

• Notify the Centre for Biosecurity without delay of any occurrences of inadvertent possession of human pathogens and toxins

• Take reasonable care, before transferring regulated materials, to satisfy themselves: that if the intended recipient is in Canada, the recipient is licensed to work with the regulated material, or is otherwise exempted from the requirement to hold a PTL or that if the intended recipient is in a foreign country, the recipient will follow applicable biosafety and biosecurity standards and policies in the foreign jurisdiction

HSE Coach responsibilities

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

• Drive conformance to the site’s HSE management systems and HSE continuous improvement of the functions they support through:

• Providing HSE coaching and mentoring to management and staff;

• Proactively monitoring HSE performance and trends and provide regular updates to management;

• Facilitates hazard identification and assists in managing HSE risk with the goal of risk elimination/reduction;

• Actively participates in Level 1 and 2 +QDCI meetings

Other duties as assigned

• Participate in HSE inspections;

• Supports hazard and near miss reporting;

• Drive on-time completion of accident reporting and investigations;

• Ensure CAPAs are effective in preventing recurrence and drive on-time completion of CAPAs;

• Drive implementation of immediate corrections to issues that don’t require a long-term action plan;

• Coordinate and/or deliver HSE-specific training;

• Have a relevent presence in the shop floor, specifically in the business areas they support;

• Support departmental Multiannual plan management;

• Acts in a timely fashion to address and/or escalates significant high-risk items that require immediate attention;

• Be flexible in providing HSE service support across shifts including occasional off shift support if applicable

• Communicates back to the HSE team on performance, current business, lessons learned, wins, and other HSE matters;

• Apply elements of the HSE management system;

• Conduct HSE risk assessments as required;

• Enforce change management techniques (HSE Requirements for Projects, change control assessments, etc.) to ensure HSE risks are identified and controlled in the design phases of projects;

• Simplification of HSE programs and procedures to make them more effective to managers and shop floor employees;

• Participate in and use HSE communication tools (safety flash, HSE blotter, etc.);

• Use the site’s CAPA tracking system in a timely fashion; and

• Participate in the weekly HSE on-call rotation for providing guidance and/or response for after-business hour situations

• Other duties as assigned by manager

Freedom to act, level of autonomy

• Works independently within the framework of the Site's HSE Management System; and

• Seeks approval from manager for key decisions related to Safety & Hygiene, Environment and Sustainability, and Biosafety and Biosecurity matters.

About You

Education/Certifications:

• Minimum Bachelors Degree in Biological Sciences, with a preference in Microbiology, or other relevant field.

• Acquired or working towards a Professional Certification (RBSO or CBSP) preferred 

Experience:

• 2-5 years of practical Biosafety experience

• Previous pharmaceutical and/or laboratory experience is preferred.

Key technical competencies and soft skills:

• Strong Knowledge of biosafety, and biocontainment principles, pathogen and toxin behaviour

• Knowledge of workplace hazards and hierarchy of controls; 

• Knowledge of HSE principles;

• Ability to have bias for action;

• Ability to make risk based decisions;

• Ability to positively influence;

• Excellent communication skills (verbal, written and presentation);

• Ability to deliver HSE related training;

• Data management skills including spreadsheets, databases is an asset;

• Knowledge of local HSE regulations and codes;

• Knowledge of systems used by HSE;

• Coaching and mentoring of managers; and

• Ability to work transversally across functions/departments and strong team work within the HSE team.

Why Choose Us?