GMP Cell Therapy Manufacturing Associate II (San Diego)

OrganaBio, LLC; San Diego (CA); On-site; USD 41,000 - 45,000; Full time

Job summary

OrganaBio, LLC, located at Excellos Labs in San Diego, CA, is hiring a Manufacturing Associate II, Cell Therapy to perform GMP aseptic cell culture tasks in a cleanroom environment. You will handle media preparation, cell thaws, expansions, harvests, and cryopreservation while following Batch Production Records, SOPs and work instructions.

The role requires strong GMP and aseptic technique, plus experience with documentation and daily production spreadsheets.

Qualifications

• 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 with 2+ years industry experience
• Strong understanding of aseptic technique and GMPs

Responsibilities

• Experience in aseptic technique, clean room gowning and GMPs
• Documenting tasks and following SOPs and BPRs
• Update production spreadsheets and communicate document readiness to management
• Document deviations and report them to management
• Process blood, cord, blood and tissue collections under cGMPs
• Set up samples for sterility testing and perform flow cytometry assays
• Execute cell culture manufacturing activities: thawing, passaging, feeding, harvesting, counting, cryopreservation, stability testing
• Handle sample processing, storage and distribution of product
• Operate daily manufacturing equipment
• Assist in revising SOPs, BPRs, work instructions and forms
• Assist with maintenance/cleaning of equipment and cleanroom
• Train others and assist in SOP updates
• Assist with ordering and stocking supplies
• Support documentation and process improvement
• Identify potential equipment or process issues
• Support safety, GMP and Quality Plan
• Participate in meetings and proficiency testing

Skills

Aseptic technique

GMP compliance

Cell culture

Flow cytometry

Documentation

Teamwork

Communication

Education

Bachelor’s degree in cell biology

Associate degree/Biotech certificate

Tools

Hemocytometer

Flow cytometer

Biosafety cabinet

Job description

OrganaBio, LLC, located at Excellos Labs in San Diego, CA, is hiring a Manufacturing Associate II, Cell Therapy to perform GMP aseptic cell culture tasks in a cleanroom environment. You will handle media preparation, cell thaws, expansions, harvests, and cryopreservation while following Batch Production Records, SOPs and work instructions.

The role requires strong GMP and aseptic technique, plus experience with documentation and daily production spreadsheets.