Manufacturing Associate III/II
2 weeks ago
ResponsibilitiesUnder 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.
QualificationsA 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 requirementsSubject 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.
CompensationThe 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.
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