Manufacturing Associate III/II

Role Summary

Fate Therapeutics is seeking a highly motivated Manufacturing Associate III/II to join the Manufacturing team to execute the manufacturing of iPSC-derived allogenic cell therapy products in the clean room, cGMP-compliant environment. The successful candidate will execute batch records, follow SOPs and perform manufacturing logistical support activities per cGMP, GDP and safety standards. The role will involve developing and applying critical skills across a variety of production activities, including but not limited to aseptic techniques, equipment operation, product sampling and enumeration, reagent and material preparation, and cell processing. The candidate will work both independently on routine activities and participate in cross-functional collaborations on more strategic and complex initiatives. This is a full-time, non-exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Responsible for the execution of cell culture manufacturing activities of iPSC-based drug product from thaw of MCBs through harvested cryopreservation and quarantine of drug product closely following approved batch records and SOPs.
• Work in a cleanroom environment, performing aseptic processing while maintaining manufacturing environmental conditions.
• Accurate and timely documentation of manufacturing activities performed.
• Responsible for documenting deviations and reporting such deviations to department management.
• Assure manufacturing facility is maintained in a clean and organized state.
• Maintain cGMP training requirements.
• Engage with supply chain and materials management to ensure adequate inventory of raw materials to support planned production activities.
• Work independently and collaboratively on manufacturing support activities.
• May identify innovative solutions and support initiation of process improvements.
• Assist in the GMP training of others.
• Performs visual inspection of drug product.

Qualifications

• Bachelor’s degree in a relevant discipline with at least 2 years of relevant experience in cell product GMP manufacturing. A High School diploma with 3+ years of relevant experience will also be considered.
• Experience in iPSC drug product manufacturing is a plus.
• Ability to read and follow manufacturing related documents including Batch Records, SOP’s, Work Instructions and Forms.
• Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced and dynamic environment.
• Familiarity with standard cell culture methods is required.
• Knowledge of cGMP regulations applicable to biologics and cell therapy manufacturing is preferred.
• Must be team oriented and flexible, striving for team success and quality results.
• Visual Acuity Testing required.

Additional Requirements

• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
• Will require working with cells and cell lines of human and/or animal origin.
• Will require working with hazardous materials.
• Will require work in controlled and cGMP Manufacturing environments requiring special gowning.
• Evening and weekend work may be required.