Cell Therapy Manufacturing Associate I

OrganaBio, LLC; San Diego (CA); On-site; USD 36,000 - 40,000; Full time

Job summary

OrganaBio is seeking a Cell Therapy Manufacturing Associate I for Excellos Labs in San Diego, CA. You will perform routine cell isolation, cryopreservation, and related tasks under GLP and cGMP, following BPR and SOPs to ensure quality and on-time production.

Responsibilities include media prep, cell counting, formulation, documentation, and equipment maintenance. Requires an Associates degree (preferred) and lab experience with GMP/ aseptic technique; training provided as needed.

Qualifications

• Laboratory experience with basic lab procedures.
• Experience with sterile technique and handling human biospecimens is preferred.
• Familiarity with GMP/GLP and aseptic technique; training provided if needed.
• Ability to perform calculations for cell concentration, viability, weights and volumes.
• Strong interpersonal and collaboration skills; effective communication within a team.

Responsibilities

• Operate under GLP and cGMP manufacturing conditions.
• Perform media prep, cell isolation, counting, formulation, centrifugation, and freezing.
• Maintain supplies, equipment, testing, storage, and distribution in scope.
• Document thoroughly and accurately per batch records and SOPs.
• Clean and maintain lab equipment and work environment.
• Conduct lab testing using techniques including flow cytometry and cell counting.
• Manage supplies ordering, stocking, and release to ensure inventory.
• Process cord blood and leukapheresis materials under cGMP/GLP.
• Analyze results and perform calculations for manufacturing processes.
• Document tasks per Excellos Labs quality plan and GMP standards.
• Update manufacturing spreadsheets daily; review and communicate document readiness.
• Report deviations to department leadership.
• Follow production schedules to meet client deliveries.
• Participate in projects and educational programs.

Skills

Laboratory procedures

Sterile technique

GMP knowledge

Cell concentration calculations

Teamwork

Communication

Education

Associates degree in science (preferred)

Job description

About this position

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 is located at Excellos Labs in San Diego, CA.

JOB SUMMARY

The Cell Therapy Manufacturing Associate I is responsible for performing routine cell isolation and cryopreservation procedures under Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP). The Associate will be responsible for performing operator and verifier activities following Batch Production Records (BPR) and Standing Operator Procedures (SOP).

RESPONSIBILITIES

• Operates under GLP and cGMP manufacturing conditions.
• Perform routine manufacturing tasks, including media preparation, cell isolation, cell counting, formulation, centrifugation, and freezing.
• Responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.
• Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols
• Performs routine maintenance and cleaning of lab equipment and environment.
• Performs laboratory testing utilizing various analytical techniques including flow cytometry and cell counting.
• Performs ordering, stocking, and release of supplies/materials to maintain supply inventory levels.
• Handles finished goods inventory and prepares cellular products and relevant documentation for shipment to customers.
• Receives and processes cord blood and leukapheresis materials under cGMP and GLP.
• Analyzes and performs calculations to assess results of manufacturing processes.
• Responsible for accurate documentation of laboratory tasks in compliance with Excellos Labs' quality plan and Good Laboratory Practices.
• Responsible for daily updating of manufacturing spreadsheets, review of completed documents, addressing corrections, and communication of document readiness to management.
• Responsible for documenting and reporting deviations to department leadership.
• Adheres to production schedules to ensure on-time production logistics and fulfillment of client requests.
• Participate in departmental and organizational projects and meetings and educational programs.

WORKING ENVIRONMENT

• 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 cells, various chemicals, and liquid nitrogen.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• May be exposed to hazardous chemicals.
• May be called on to work or attend meetings at other than routinely scheduled hours.

PHYSICAL REQUIREMENTS

• Must be able to stand or sit long hours.
• Must be able to work on a computer 4 - 8 hours a day.
• Must be able to communicate clearly.
• May be required to lift up to 40 pounds.

EQUIPMENT USED

• Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, automated 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:

• An Associates degree in science related field is preferred.

Skills:

• Laboratory experience with working knowledge of basic lab procedures.
• Previous experience with sterile technique and handling human biospecimens.
• Familiarity with standard cell culture methods is preferred Excellos will train an acceptable candidate
• Basic understanding of aseptic technique and Good Manufacturing Practices (GMP).
• Ability to work under minimal supervision.
• Ability to perform calculations including cell concentration determination, % viability, weight measurements, and volume.
• Interpersonal skills to establish and maintain professional relationships both internally and externally.
• Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.
• Ability to work well under pressure and meet critical timelines.
• Ability to work, learn, adapt, and execute in a fast-paced commercial environment.

Certifications/Licenses:

• Biotech certificate valued, not required

This position works 4 x 10 hour days: Tuesday - Friday.

Salary range: $26.50 - $29.50 per hour