Cell Therapy Manufacturing Associate II

Organa Bio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most.

Headquartered in Miami, Florida, Organa Bio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation. This position will work at the newly formed Organa Bio subsidiary Excellos Labs, LLC (“Excellos Labs”) located in Downtown San Diego, California.

The Manufacturing Associate II, Cell Therapy is responsible for performing well regulated GMP aseptic cell culture activities including media preparation, cell thaws, cell expansion, cell harvesting, and cryopreservation using standard cell culture technologies in a cleanroom environment. The Associate will be responsible for following Batch Production Records, Standard Operating Procedures, and work instructions in manufacturing spaces. The Associate will be responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.

• Experience in aseptic technique, clean room gowning and have knowledge of Good Manufacturing Practices (GMPs).
• Documenting of each task, understanding verifier versus operator functions, following cleaning procedures, and ensuring aseptic processing techniques.
• Daily updating of Production spreadsheets, review of completed documents, addressing corrections, and communication of document readiness to management.
• Responsible for documenting deviations and reporting deviations to department management
• Receipt and processing of blood, cord, blood, and tissue collection processes under cGMPs.
• Set up samples for sterility testing, perform flowcytometry assays for viability and cell identification.
• Responsible for execution of cell culture manufacturing: cell thawing, cell passaging, cell feeding, harvesting, cell counting, cryopreservation, and stability testing.
• Performs sample processing, intermediate formulations, storage, and distribution of product
• Operation of supporting equipment for daily manufacturing.
• Train on and actively participate in revising Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Work Instructions, and Forms.
• Assist with the weekly maintenance/cleaning of equipment and cleanroom to support GMP production.
• Assist Subject Matter Expert (SME) with providing training for new and existing employees.
• Assist with the ordering, stocking, and release of supplies/materials to meet production demands.
• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.
• Help identify potential equipment or process issues.
• Supports the Excellos safety, GMP and Quality Plan.
• Participates in department meetings, proficiency testing, and educational programs.

• Must work with living human cells and various chemicals.
• ISO 7 and ISO 8 clean room facilities, including sterile gowning garments
• Normal laboratory environment with biohazard precautions.
• Must work with living human cells and various chemicals.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• Will be working with liquid nitrogen.
• May be called on to workdays or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if…