Manufacturing Associate Iii/ii - San Diego, United States - Fate Therapeutics
Description
Responsibilities:
- Under direction, execute cell culture manufacturing activities of iPSCbased 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 problemsolving 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 crossfunctionally 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 mínimal supervision is required.
- Selfmotivated, flexible, able to prioritize, multitask, and work in a fastpaced 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.
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