Operations

• Coordinate and enable seamless collaboration across Manufacturing, Quality, Facilities, Materials Management, MSAT, and IT to support clinical manufacturing operations
• Assess manufacturing processes in alignment with QC testing workflows to optimize execution from blood intake through patient delivery and product release
• Develop SOPs and procedures to support efficient and compliant production processes
• Support logistics management for delivery of starting materials from donors and drug product shipments to customers
• Ensure documentation and preparations for blood and graft pickups and deliveries
• Oversee timely completion of post-run closeout documentation, including upload of data files, temperature reports, and Bill of Materials, for QA review
• Execute cold storage practices and cryopreservation of drug products as needed
• Assist QA in tracking and reporting metrics such as cycle times and production efficiency
• Schedule and send logistics-related calendar invites (e.g., conditioning, sample drop-offs, and sample requests) to relevant teams
• Contribute to special projects focused on innovation and development of upcoming Orca products
• Update and implement SOPs and batch records as needed to reflect process improvements and operational changes
• Support capacity planning and production ramp-up initiatives to meet growing clinical demand at the Sacramento facility

Operations and Logistics Support Manager

Operations Team Member

Sales Strategy – Operations Manager