Job Description

Temporary Full-time () - HSC RPS-ENVI/STER PROG

Zone:

Eastern Urban Zone

Location: Health Sciences Centre

Clinical Microbiologist

(Subject to Classification Review)

Medical Imaging

Radiopharmaceutical Sciences (Nuclear and Molecular Imaging)

Temporary Full-time (until May 30, 2027, with the possibility of extension)

MGMT

29451RP1

Hours

70 bi-weekly (8-hour shifts; days, nights, evenings, weekends)

Salary

HL-24 (CAD86,572- CAD112,544 per annum)

Competition Number

VAC0015260

Posted Date

2025-10-17

Closing Date

2025-10-24

Demands, duties, qualifications

Job Summary

NL Health Services are seeking a Microbiologist to support the clinical work of the Radiopharmaceutical Sciences. Reporting to the Manager of Radiopharmaceutical Sciences and Cyclotron Operations, the Microbiologist will lead the development and implementation of a Sterility Testing Program in alignment with guidance document USP <71> and Health Canada regulatory requirements. This is a unique opportunity to design and validate sterility testing protocols from the ground up in a fast-paced, quality-driven environment.



The Microbiologist works directly with a team of healthcare professionals within the Nuclear and Molecular Medicine program. The Nuclear and Molecular Medicine facility is equipped with an IBA 18/18 cyclotron to support Single Photon Radiopharmaceutical (SPR) and the Positron Emitting Radiopharmaceutical (PER) production, as well as a cold chemistry laboratory and, in the future, an animal imaging laboratory.



The Microbiologist will be responsible for the development and implementation of all the documentation, validation, and training of staff for the expansion of the Radiopharmaceutical Sciences program sterility lab.



The Microbiologist will also be required to collaborate with internal and external stakeholders and lead process improvements within the department and must ensure that all activities are carried out by following established Quality Assurance/Quality Control procedures, applicable environmental and safety regulations, and other requirements as necessary.

Job Demands

By applying for this job, you acknowledge and understand that regular requirements and demands of this job include (but are not limited to):


Designing, implementing, and managing a robust

sterility testing program

that complies with

USP <71>

and

Health Canada guidelines

.

Developing and validating test methods, SOPs, and protocols for sterility testing. Establishing and maintaining a controlled environment and aseptic techniques suitable for sterility testing (e.g., isolator or cleanroom-based systems). Selecting appropriate test media, incubation conditions, and monitoring systems. Training and supervising laboratory staff in sterility testing procedures. Overseeing environmental monitoring and microbial risk assessments related to the sterility testing process. Ensuring documentation, investigations, and reports meet cGMP, USP, and Health Canada expectations. Supporting regulatory submissions and inspections by providing technical documentation and responding to agency queries. Collaborating cross-functionally with Quality Assurance, Production, and Regulatory Affairs.

Preparing various reagents used in the developed process. Completing all required documentation and records to meet the requirements of current GMP guidelines and in compliance with Good Documentation Practices. Regularly moving or lifting objects between 10-50+ lbs., such as shielded radioactive sources and lead bricks.
This position presents a high responsibility to protect self and others from radiation exposure.
Constantly sitting to perform paper/computer work and operation of remote equipment; regularly walking or standing to perform radiopharmaceutical production, cyclotron, and equipment maintenance. Regularly performing fine finger/precision computer work; handling of open source radioactivity and radioactive equipment/components requiring steadiness and accurate movement/control. Regularly working in confined/awkward spaces where reaching, bending, and crouching are required to complete maintenance work. Time sensitive work to meet clinical and research demands.

Personal Protective Equipment (PPE) is a regular requirement, including gloves and gowns.

Job Qualifications

PhD degree in Microbiology, Biological Sciences, or related field
Minimum

5 years of microbiology experience

in a GMP-regulated pharmaceutical, biotechnology, or medical device environment. Strong working knowledge of

USP <71>

, USP <797>/<800>, and Health Canada

Guidance for Sterile Products

.

Hands-on experience with sterility testing in an isolator or cleanroom environment. Demonstrated experience in developing and validating microbiological methods. Familiarity with environmental monitoring, aseptic processing, and contamination control. Experience with the use of radionuclides or experience in radiochemistry is an asset. Experience working with analytical equipment used for the quality control of radiopharmaceuticals is an asset. Knowledge of Canada's regulatory framework relative to radiopharmaceuticals including radiation safety (CNSC) and GMP (Health Canada) is an asset. Demonstrated superior skills in working with the latest electronic and computer technology systems. Demonstrated strong organizational skills. Demonstrated ability to collaborate effectively and build and maintain effective working relationships.
Excellent oral and written communication skills.
A satisfactory record of work performance and attendance is required.

* If there are no applicants with the above qualifications, applicants with alternate combinations of education and/or experience may be considered.