Scientist, Quality Control

Fate Therapeutics, Inc. is seeking a highly motivated Scientist of Quality Control (QC) with ddPCR and other molecular assay experience to support its cellular therapy programs. This role will focus primarily on ddPCR analytical methods and will also cross-train on flow cytometry and cell based analytical methods.  This role will be responsible for providing oversight and support for execution, optimization, transfer, qualification, and validation of analytical methods supporting manufacturing in-process control (IPC) and lot release of product, within a Good Manufacturing Practices (GMP) environment. The successful candidate will have experience participating in high performing teams executing analytical test methods, working with mammalian cell culture, analyzing emerging data to assess the characteristics of hematopoietic and stem cell-based therapeutics, and GMP method qualification and validation. This role requires extensive interaction with Research & Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and Contract Manufacturing Organizations (CMOs). This is a full-time position located at our corporate headquarters in San Diego, CA.
Responsibilities

• Perform GMP IPC, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based methods.
• Facilitate and perform method optimization, transfer, qualification, and validation for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GMP environment. 
• Report results in detailed and organized presentations and reports.
• Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.
• Manage equipment onboarding activities as needed, including completion of required documentation and managing validation activities.
• Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.
• Participate in lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
• Assist in the implementation of new assay methodologies and the associated instrumentation.
• Identify and support initiation and completion of deviations, CAPAs, and laboratory investigation.
• Perform data trending analysis and present findings at cross-functional meetings and contribute to regulatory filing updates.
• Participate in and prepare for regulatory audits including representing Quality Control in auditor-facing roles as well as supporting lab audit readiness activities.
• May supervise or mentor junior team members.  

Qualifications

• Ph.D. in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline with a minimum of 2 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is preferred. Masters degree with 6+ years of relevant and progressive experience may be considered.  
• Experience working in a cGMPP Quality Control lab is required.
• Experience running ddPCR assays required.
• Experience running multicolor flow cytometry, with working knowledge of BD flow cytometers, BD FACSDiva software, and FlowJo preferred.
• Experience working with cell culture, human blood, and blood products using sterile technique.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.

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
• May require work in controlled and cGMP Manufacturing environments requiring special gowning

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.

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 $120,000 to $135,000 per year.