Cell Therapy Manufacturing Associate I or II in San Diego, California at OrganaBio, LLC

OrganaBio 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, OrganaBio 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 OrganaBio subsidiary Excellos Labs, LLC (“Excellos Labs”) located in Downtown San Diego, California.

The Cell Therapy Manufacturing Associate I or II 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.

RESPONSIBILITIES

• 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.

• Execution of colony forming units assay procedures (CFUs), set up samples for sterility testing, performs 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 of Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Work Instructions, and Forms.

• Supports environmental monitoring processes including personnel monitoring, suite monitoring as defined by the facility

• 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, 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.

WORKING ENVIRONMENT

• 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.

• May be exposed to hazardous chemicals.

• 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 necessary.

PHYSICAL REQUIREMENTS

• Must be able to stand long hours.

• Must be able to sit at biosafety cabinet for hours, while aseptically manipulating product.

• Must be able to communicate clearly.

• May be required to lift 50 pounds.

EQUIPMENT USED

• Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, flow cytometers, incubators, bioreactors, cell separators).

• Normal office equipment such as: telephone, computer, cell phone, printer, copier, fax, scanner.

• General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, refrigerators, freezers).

QUALIFICATIONS

Education:

• Bachelor’s degree in cell biology or related field with 1+ years industry experience

or

• Associate degree in related area and/or a Biotech Program certificate from an accredited college with 2 + years industry experience.

Skills:

• Strong understanding of aseptic technique and Good Manufacturing Practices (GMP).

• Proficient in standard cell culture methods including cell counts using Hemocytometer, perform calculations including cell concentration determination, seeding densities, % viability, weight measurements, and volume.

• Interpersonal skills to establish professional relationships both internally and externally.

• Critical thinking, creativity, and innovative thinking.

• Detail oriented with the ability to set priorities and organize daily work requirements.

• Must be able to work both as a team member and independently, as required.

• Proficient in professional communication both written and oral, which is clear and precise.

• Must keep Management informed on any technical and/or operational issues that arise.

• Must be flexible, as production priorities, timelines, and processes can change regularly.

• Integrity and discretion – ability to maintain confidentiality.

• Ability to perform under pressure and work under stressful situations.

Certifications/Licenses:

• Biotech certificate valued, not required

This position is on site in San Diego, CA.

Shift: Tuesday - Friday 8:00am - 6:30pm

Salary range: Range $27 - $32 per hour