BLES Biochemicals Inc. is a privately-owned, proudly Canadian pharmaceutical and medical device manufacturer and distributor. Our pharmaceutical product, BLES®, is a life-saving pulmonary surfactant used to treat premature infants who have respiratory distress syndrome. BLES® was discovered at Western University and continues to be manufactured in London, Ontario. In 2015, BLES® was ranked as one of the top five discoveries at an Ontario university, alongside insulin. Our product is the market-leading surfactant in Canada and several other countries, and it treats tens of thousands of patients annually.

The team at BLES Biochemicals works hard to manufacture exceptional products; the welfare and happiness of patients and their families are our top priorities. Our vision is to live in a world where every premature baby has access to life-saving pulmonary surfactant therapy. There is still a long way to go, and we hope that you’ll join us on this journey.
 

• Review Raw Material release testing documentation (in-house, contract lab)
• Review drug product and drug substance analytical test result documentation (in-house, contract lab)
• Oversee the approved vendor certification program
• Review instrument calibrations for QC/Production equipment
• Oversee calibration/PM of Laboratory equipment, review calibration results
• Review stability data and write reports. Perform ongoing trending of QC release and stability data
• Document deviations/out-of-specification investigations
• Write and review controlled documents relevant to the Quality Department
• Vial Inspection (lead); oversee vial inspection, including training and scheduling of inspectors
• Review 21CFR11-compliant software reports and audit trails.
• Verification of coded packaging information