Manufacturing Associate III/II

Fate Therapeutics is looking for two Manufacturing Associates III or II to join our Manufacturing team to execute cell culture activities of iPSC-based Drug Product from thaw of Master Cell Banks through harvested cryopreservation and quarantine of Drug Product. The ideal candidate will have at least 2 years of experience in the GMP Manufacturing area for cell products. This is a full-time, non-exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Under direction, execute 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.
• Assure manufacturing facility is maintained in a clean and organized state.
• Engage with supply chain and materials management to ensure adequate inventory of raw materials to support planned production activities.
• Maintain cGMP training requirements.
• Work independently and collaboratively on manufacturing support activities.
• Identify innovative solutions and support initiation of process improvements.
• Supports and performs specialized tasks of a GMP trainer.
• Performs visual inspection of drug product.
• Troubleshoots processing issues in the clean room and demonstrates problem-solving skills.
• Proactive with clean room activities by regularly taking initiative and demonstrating good judgement.
• May perform critical GMP related tasks including material and batch record requests and GMP room readiness.
• Collaborates cross-functionally with Quality and manufacturing support staff.

Qualifications

• A High School diploma is required with at least 3 years of experience in the GMP Manufacturing area for cell products, or a Bachelor’s degree in a relevant discipline with at least 2 years of applicable experience.
• Experience in iPSC drug product manufacturing is preferred.
• Ability to read and follow manufacturing related documents including batch records, SOP’s, Work Instructions, and Forms.
• Ability to work independently or with minimal supervision is required.
• 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.

Working conditions & physical 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.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated rate for this role is $30.00 to $40.00 per hour.