Aurion Biotech

Operations

• Works with external QC laboratories to review and track GMP in process, release and stability testing
• Real time review of DP release data during harvests and CoAs as part of a rapid release strategy.
• Leads QC data compilation and shares in cross-functional settings.
• Able to work with CMO on out-of-specifications and investigations as needed.
• Designs DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO.
• Supports technology transfers through data and document review.
• Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions.
• Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met.
• Be able to help support regulatory personnel with supportive documents related to regulatory filings.

Senior Scientist, Quality Control Operations

Engineer

• The Senior Cold Chain Engineer will own the design, implementation, optimization, and continuous improvement of LN2 and temperature-controlled supply chain systems supporting research, clinical, and future commercial operations
• Cold Chain System Design & Engineering
• Lead the selection, qualification, and lifecycle management of LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
• Build cold chain capabilities to support R&D, clinical trials, and future commercial scale
• Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities
• Ensure cold chain operations comply with GxP, and internal quality standards
• Act as the technical lead for cold chain vendors, couriers, and logistics providers
• Define KPIs and dashboards for cold chain performance