Job Description

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-\xce\xb1 (FAP-\xce\xb1), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN CANADA. Location of work This position will be located onsite downtown at UHN near University Avenue and College Street. Overview Reporting to Senior Production Manager, the EHS and Radiation Safety Specialist will provide site-level radiation safety support, environmental, health, safety and promote regulatory compliance at a complex radiopharmaceutical manufacturing facility. The Specialist will bridge the gap between University Health Network (UHN), Johnson and Johnson Innovation (Jlabs) and Point Biopharma for job and radiation safety and ensure compliance of all applicable POINT staff with the UHN radiation safety policies. The Specialist will be a Subject Matter Expert on the handling, storage, and disposal of radioactive materials in use at the facility. Focus will be on taking ownership of the day-to-day radiation safety and general safety programs, as well as fostering the continuous improvement of existing processes, procedures, and controls. This role will also be involved in emergency preparedness and response, acting to prevent and mitigate spills, contamination events, and exposure excursions. The position is based in Toronto, Ontario, Canada and observes typical business hours, Monday through Friday. Some evening or weekend work may be required on a minimum basis, as dictated by the production schedule onsite.
Objectives

• Working with UHN, Jlabs and POINT Indianapolis, develop and implement a comprehensive site-specific Environmental, Health, and Safety Program that encompasses all aspects of radiochemical development, manufacturing, testing, packaging, and waste management.
• Maintain all necessary wastewater, hazardous waste, solid waste, and other environmental reporting and permits.
• Provide comprehensive Job Hazard Analyses (JHA) and provide field presence for various manufacturing and laboratory activities to ensure appropriate controls are being utilized and JHA recommendations have been appropriately implemented.
• Devise and aid in the development, implementation, and improvement of radiation safety procedures outline by UHN.
• Ensure SDS and chemical inventories are current and accessible to all site personnel, updating the hazard communication program as necessary
• Contribute to or lead complex projects of large scope related to initiatives that expand radiological product research, development, and/or manufacturing.
• Evaluate contamination control practices, operational workflow, shielding design, and As Low As Reasonably Achievable (ALARA) controls for new projects or non-routine work.
• Respond to radiological incidents in such a way as to minimize risk to site personnel as well as the surrounding community and environment.
• Collaborate with POINTs Environmental, Safety, and Health personnel to maintain coverage of critical tasks and a well-aligned view of the safety program.

Accountabilities

• Assist in the development and operation of air, wastewater, hazardous waste, solid waste, and other environmental monitoring and disposal procedures, and associated reporting and permits.
• Collaborate with site leadership to understand and address areas of opportunity and drive continuous improvement.
• Act as a subject matter resource for site staff on the full suite of COHS, CCMTA, CEPA and similar federal, provincial, and local regulations.
• Prepare and deliver ongoing radiation safety training with the goal of driving safety-first culture and zero safety-related incidents in the facility.
• Audit and inspect the facility to ensure compliance with company, provincial, and federal regulations - offering solutions and facilitating effective implementation of corrections to any audit findings.
• Participate in corporate and regulatory compliance audits and inspections; interact with regulators, auditors, and investors during assessments - leading efforts to address identified gaps.
• Participate in corrective action / preventive action development and implementation as a part of radiological safety incident investigations.
• Evaluate and aid in the control of potential employee radiation exposure encountered in the workplace through the use of appropriate tools, risk analysis techniques, and assessments.
• Foster a safety conscious work environment where employees are encouraged to raise safety concerns by promptly reviewing any concerns, assigning proper priority based on potential safety significance, and appropriately resolving the issue with timely feedback to the originator of the concern and to other employees as appropriate.
• Apply scientific principles to the evaluation and resolution of radiation safety-related opportunities for improvement.
• Effectively communicate moderately complex radiological issues and solutions to a cross functional team.
• Work independently or as a member of a cross-functional team to develop and execute surveys or trials, perform root cause analyses, and participate in investigations.
• Engage in cross-functional teams in the implementation of EHS / radiation safety programs and the tabulation of relevant safety metrics.
• Assist production, QC, maintenance, and shipping staff in the development of their function specific procedures with regard to operational radiation safety issues and waste management.
• Act as a member of the facility emergency response team and assist in regulatory reporting and correspondence with regulatory agencies as required.
• Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study.
• Exercise technical judgment in planning, organizing, performing, and/or coordinating work which may pose a radiological risk.
• Identify and routinely use the safest, most effective, cost efficient and best practices to execute processes; continually evaluating their effectiveness and appropriateness.
• Comply with Canadian Nuclear Safety Commission (CNSC) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Maintain regulatory required documents and records in an organized fashion.
• Perform other duties as assigned.

Requirements

• BS / BA degree in basic science required; health physics, radiological health, or other health science or occupational health major is preferred.

• MS in health physics, environmental science, occupational health, or industrial hygiene preferred.
• Minimum 3 years of related experience.
• Ability to read and interpret safety data sheets is required.
• Experience working in a pharmaceutical GMP manufacturing environment is preferred.
• Ability to properly don clean room garments on a frequent basis.
• Capable of lifting up to 40lbs on an occasional basis.
• Able to wear respiratory protection equipment.
• Motor abilities: sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control.
• Visual and audio-focused work and ability to perform role in personal protective equipment.
• Work conditions: stairs, typing/keyboard, standard and/or sitting working environment of > 8 hrs/day.
• Work hours are during core business hours with the flexibility to be on-call outside of core business hours to respond to incidents that may occur.

Competencies

• Strong organization and time management capabilities, including coordination and prioritization of multiple projects and tasks.
• Able to function independently, demonstrating self-motivation and initiative.
• Strong communication skills, including as a trainer in large group settings.
• High degree of trust and integrity, open communication, display respect and desire to foster teamwork.
• Demonstrated ability to function well in a collaborative team environment.
• Demonstrated ability to evaluate radiation safety risks and determine solutions.
• Flexible and able to quickly adjust to new or changing projects/tasks and schedules.

Benefits

• Healthcare plan (medical, dental, vision) - effective day 1

• Disability
• Life insurance
• RRSP matching plan
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement
• $50 cell phone reimbursement per paycheck ($1,300 per year)

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law. This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered. POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. We do not accept unsolicited inquiries or resumes from agencies.