Manufacturing Associate III/II

Fate Therapeutics is looking for a highly motivated and detail-oriented Manufacturing Associate III/II to join our 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 candidate will develop and apply 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.

Working Conditions

• 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 salary range for this role is $30 - $37/hr

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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About Fate Therapeutics, Inc.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 diseases. 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.

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