Cell Therapy Manufacturing Associate I - GMP Cell Ops

Organabio,-LL

San Diego (CA)

On-site

USD 60,000 - 85,000

Full time

5 days ago
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Job summary

OrganaBio in San Diego, CA, seeks a Cell Therapy Manufacturing Associate I to perform routine cell isolation and cryopreservation under GLP and cGMP, following Batch Production Records (BPR) and Standing Operator Procedures (SOP).

You will work in ISO 7/8 clean rooms, handle cord blood and leukapheresis materials, and maintain accurate documentation while supporting manufacturing and client needs. Training provided for GMP, with cross-functional collaboration.

Qualifications

  • Associates degree in science related field preferred.
  • Laboratory experience with basic lab procedures.
  • Sterile technique and handling human biospecimens recommended.
  • Familiarity with cell culture and GMP principles preferred.
  • Ability to perform cell counting, viability, and concentration calculations.
  • Strong teamwork and clear communication required.

Responsibilities

  • Operate under GLP and cGMP manufacturing conditions.
  • Perform media preparation, cell isolation, counting, formulation, centrifugation, and freezing.
  • Maintain supplies, equipment, and documentation per GMP standards.
  • Document batch records and SOPs accurately and timely.
  • Perform equipment cleaning and maintenance.
  • Conduct laboratory testing including flow cytometry and cell counting.
  • Manage inventory and release of materials for shipment to customers.
  • Process cord blood and leukapheresis materials under cGMP and GLP.
  • Analyze manufacturing data and report deviations to leadership.
  • Update manufacturing spreadsheets and ensure document readiness for management.

Skills

Lab experience
Sterile technique
Cell culture familiarity
GMP knowledge
Calculations
Team collaboration
Communication
Adaptability

Education

Associates degree in science related field

Tools

Flow cytometer
Centrifuge
Incubator
Biosafety cabinet
Automated cell counter

Job description

OrganaBio in San Diego, CA, seeks a Cell Therapy Manufacturing Associate I to perform routine cell isolation and cryopreservation under GLP and cGMP, following Batch Production Records (BPR) and Standing Operator Procedures (SOP).

You will work in ISO 7/8 clean rooms, handle cord blood and leukapheresis materials, and maintain accurate documentation while supporting manufacturing and client needs. Training provided for GMP, with cross-functional collaboration.

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