Process Engineer III MSAT

Profile

Fate Therapeutics is seeking an enthusiastic and skilled Tech Transfer Process Engineer to join our company’s MSAT Technology Transfer (MSTT) team. The successful candidate will be responsible for tech transferring state-of-the art technologies for Fate Therapeutics novel, off-the-shelf, engineered iPSC-derived NK and T cell therapy manufacturing. The candidate will collaborate with multidisciplinary teams on late-stage process development, tech transfer, and commercial readiness. The candidate will provide engineering and technical subject matter expertise in tech transfer, process validation, risk management, and life cycle management. Furthermore, they will actively support manufacturing by providing technical support in troubleshooting, investigations, and process improvements, and training for late-stage tech transfers. This is a full-time position reporting to the Senior Manager of MSTT. This position will be based out of Fate’s corporate headquarters in San Diego, CA.
Responsibilities

• Lead execution of process qualification & validation protocols, revalidations, and commercial readiness activities.
• Lead tech transfer development activities by executing process performance capability studies, process performance analysis, process mapping, process transfer protocols, qualification studies, and trainings.
• Support implementation of new technologies by drafting documents into the quality management system; batch records, BOMS, SOPs, product/process/material specifications, & qualification documents.
• Lead and/or participate risk management activities to identify manufacturing & quality gaps
• Ensure robust manufacturing data capture, monitoring, trending, and analysis.
• Provide subject matter expertise to support manufacturing troubleshooting, deviations, investigations, CAPAs, and change controls.
• Enable developmental success by providing key MFG feedback of data trends and analysis to ensure process variation and control are maintained after process changes are implemented.
• Recommend process improvements, control strategies for upstream/downstream manufacturing processes.
• Evaluate and support implementation of automated manufacturing systems MES/EBR/PIMS.
• Perform late-stage process development and characterization of upstream and downstream processes.

Qualifications

• Bachelor’s or Master’s degree in Biochemical/Chemical Engineering, Biotechnology, or Biological Sciences with a minimum of 4 years cGMP experience in tech transfer, process engineering, manufacturing engineering, and/or process validation
• Experience with phase 3 to commercial experience highly preferred
• Experience with project management highly preferred
• Experience with quality by design methodology and practice preferred
• Experience with aseptic cell culture in a cGMP environment preferred
• Experience with automated manufacturing execution systems or electronic batch records a plus
• Experience with downstream fill-finish, visual inspection, and cryopreservation a plus
• Experience with wave, stirred-tank bioreactor, PAT, and automated cell culturing a plus
• Experience with such as Excel, JMP, Spotfire, GraphPad Prism, Visio
• Knowledge of quality systems document routing, CAPAs, deviations, impact assessments, document change controls, and change management
• Excellent communication, organizational, and problem-solving skills

Working Conditions and Physical Requirements

• On-site work at corporate headquarters in San Diego, CA with occasional travel (<10%)
• May require traveling for audits, FAT’s, conferences, trainings, or other business-related activities.
• Will require working with cells and cell lines of human and/or animal origin
• Will require working with hazardous materials
• Will require working within PD & cGMP environment
• Evening and weekend work may be required

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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit ****rel=no-follow>****/>,datePosted:2022-02-25T05:49:50 00:00,validThrough:2022-03-27T04:00:00 00:00,employmentType:FULL_TIME,hiringOrganization:{name:Fate Therapeutics, Inc.,@id:396217,url:****Diego, CA,address:{addressCountry:US,addressLocality:California,addressRegion:California,postalCode:92121,@type:PostalAddress},@type:place},industry:Engineering, Manufacturing & Production, Process,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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