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Manufacturing Associate III/II

Employer
Fate Therapeutics
Location
San Diego, CA
Start date
May 17, 2024

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Job Details

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.

Company

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Company info
Website
Phone
858.875.1800
Location
12278 Scripps Summit Drive
San Diego
California
92131
US

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