Senior Microbiologist

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

You will be part of one of API's most important projects, the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region.

One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMP-certified manufacturing suites for API-manufacturing, chemical-physical testing, and Health Canada-approved warehousing capacity.

The second part of the project is the Critical Medicines Production Centre (CMPC), which will be a new 83,000+ square‑foot manufacturing facility located on a 7‑acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canada’s largest and best equipped of its kind. The CMPC's focus will be on producing small‑molecule product solutions, conducting sterile, aseptic fill, and finishing traditional and biologic drugs to meet drug shortages needs.

The Senior Microbiologist is responsible for leading and supporting microbiology operations for a GMP‑compliant sterile pharmaceutical manufacturing facility. This role oversees the implementation and qualification of microbiology laboratory systems, environmental monitoring programs, contamination control strategies, and microbiological testing to ensure compliance with Health Canada, FDA, EU GMP, and Annex 1 requirements.

Please note this position requires full‑time on‑site presence.

• Knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile pharmaceutical products.
• Assist in qualification of a new CMPC Microbiology Lab to meet GMP requirements.
• Leading Qualification activities and writing URS, VRA, VP and other qualification documents for microbiology‑specific instruments such as autoclaves, incubators, Vitek and other laboratory equipment common in the GMP testing micro lab.
• Write procedures for environmental monitoring systems and microbiology lab operations for new sterile manufacturing facility (CMPC)
• Qualify equipment and perform risk assessments for environmental monitoring.
• Assist Media‑fill strategy and cleaning procedures together with production.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• Providing daily in‑lab mentorship to the microbiologists, fostering strong techniques, aseptic practices, and microbiological best practices.
• Reviewing microbial data, protocols, reports, and testing documentation.
• Extensive Knowledge of EMPQ and EU Annex 1 guidelines.
• Ability to perform comprehensive gap analysis and implement actions to meet requirements.
• Set up a contamination control strategy for the site.
• Act as Alternate Biosafety Officer and write procedures to support HPTA and DEL License.

• Perform raw materials, in process, water, clean steam samples and sterility testing.
• Perform routine environmental monitoring for the clean rooms.
• Perform routine record review and data analysis to identify trends.
• Update management on trends and implement corrective action plans when necessary.
• Writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
• Experienced with handling wide range of microbiological equipment like Isolator, Vitek 2 compact, Biosafety Cabinets, Autoclave, Incubators, particle…