Job Description & How to Apply Below
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.
Important:
This position requires full‑time on‑site presence.
Key Responsibilities
Validation & Compliance
Set up validation strategies.
Set up cleaning validation strategies and processes.
Define cleaning limits for API‑reaction vessels and formulation tanks.
Write and review validation protocols and reports in collaboration with the team.
Write and review cleaning validation protocols and reports.
Assist with and review media fill plans and reports.
Ensure regulatory compliance and operational efficiency throughout process development and manufacturing scale‑up.
Prepare for and support regulatory inspections with global health authorities.
Defend validation and technology transfer strategies during inspections.
Process Implementation & Scale‑Up
Responsible for commercial implementation of customer products or products transferred from Translational Services Division.
Responsible for Product areas:
Chemical‑API‑production (small to mid scale) and sterile liquid injectable products from Formulation, Filling, Terminal sterilization, Inspection, Packaging.
Work closely with the Translational Services Division and R&D‑departments to transfer new or generic products.
Assist the Project Manager in project‑planning and material and personnel resource capacity in Technical Operations.
Support analytical method transfers and process implementation activities.
Optimize manufacturing parameters to improve efficiency, robustness, and scalability.
Define Critical process parameter for the production processes.
Set up engineering batches and improvements until commercialisation.
Perform process gap analysis, fit‑to‑plant assessments, equipment/process characterization, and scale‑up activities.
Conduct FMEA‑based risk assessments to support robust manufacturing processes.
Implement SOPs, and tools to support repeatable and efficient product implementation projects.
Manufacturing & Technical Operations
Lead technical investigations and problem‑solving activities supporting commercial manufacturing operations.
Collaborate closely with the Translational Services Division, Engineering, Operations, and Commercialization teams to identify suitable equipment vendors and process flows.
Support layout design, throughput optimization, safety standards, and facility fit considerations.
Work with Procurement team together for implementation of Drug Substance and Drug Product material supply strategies, including vendor and project management.
Documentation & Quality Systems
Author…
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