• Managed Drug Product Operations technicians, engineering specialists and project schedule to ensure the successful completion of production campaigns to meet client deliverables and revenue targets.• Developed and managed yearly capital equipment budget ($1M budget) for department and strategized equipment purchasing to upgrade processing capabilities for upcoming projects.• Designed furniture and equipment layout and determined utility/finish requirements of analytical lab capital… Show more • Managed Drug Product Operations technicians, engineering specialists and project schedule to ensure the successful completion of production campaigns to meet client deliverables and revenue targets.• Developed and managed yearly capital equipment budget ($1M budget) for department and strategized equipment purchasing to upgrade processing capabilities for upcoming projects.• Designed furniture and equipment layout and determined utility/finish requirements of analytical lab capital project ($800,000 budget) based on URS of end users.• Communicated and worked with clients to complete tech transfer of programs and ensured the smooth operation of batches. Worked with auditors to identify areas for improvement in GMP processes.• Oversaw monthly Drug Product Operations revenue forecasting to ensure department is performing towards yearly revenue targets of $7-8M• Executed cleaning verification studies of equipment that is shared between programs. Show less

• Coordinated and managed capital projects with budgets between $100,000 - $800,000 to complete building upgrades and comply with health/fire code regulations.• Generated and executed protocols and amendments for installation and operation qualification of equipment including fume hood, environmental monitoring system, ribbon dryer, mixing tank, etc.…• Organized GMP equipment calibration schedule to ensure equipment remains in compliance. • Updated SOPs of GMP equipment and… Show more • Coordinated and managed capital projects with budgets between $100,000 - $800,000 to complete building upgrades and comply with health/fire code regulations.• Generated and executed protocols and amendments for installation and operation qualification of equipment including fume hood, environmental monitoring system, ribbon dryer, mixing tank, etc.…• Organized GMP equipment calibration schedule to ensure equipment remains in compliance. • Updated SOPs of GMP equipment and procedures to improve efficiency and safety practices.• Managed site-wide health and safety program to ensure compliance with OHSA and Ministry of Labour regulations, scheduled monthly safety inspections and performed incident investigations. Show less

• Analyzed and wrote detailed reports on how material defects impact production time loss in filling lines.• Worked with suppliers to correct material issues and test new products before GMP introduction.

• Managed raw material inventory and worked in a GMP setting with team members to meet batch production deadlines to support upstream processing.• Collaborated with R&D in assisting with process validation and implementation and testing of new aseptic processes for production by assembling equipment.• Exhibited teamwork with other production departments to maintain 100% on time delivery of required media and raw materials in addition to last minute production requests.