Cell Therapy Manufacturing Associate II

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

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 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.

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.
• 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.

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 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 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 works 4 x 10 hour days: Tuesday - Friday.

Salary range: $29.50 - $32.50 per hour

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