Associate Scientist, Quality Control Lab Operations

Fate Therapeutics is looking for a motivated Associate Scientist to join the Quality Control team to oversee the Quality Control Laboratory operations. This is a cross functional and key position for successful lab management, as well as tech transfer and validation. The successful candidate will have robust experimental skills in a biotechnology, clinical, or pharmaceutical laboratory. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

Responsible for supervising all QC Laboratory operations, including lab cleaning, product testing, lab supply purchasing, lab equipment oversight and laboratory projects.

Act as system owner for all QC equipment qualification and equipment qualification documents.

Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.

Sample management oversight, including scheduling sample receipt, benchwork, laboratory maintenance activities, laboratory projects, data review, and data entry.

Coordinates all QC sample management for testing performed at external laboratories (Contract testing organizations). Interacts with suppliers and customers as needed.

Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.

Maintains GMP/GLP laboratory logbooks and documentation relevant to the duties and responsibilities assigned.

Perform periodic internal QC system reviews and audits, as well as participate in preparing for and representing QC in regulatory inspections.

Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.

Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.

Identify and support initiation and completion of deviations, CAPAs, OOS, and laboratory investigations.

Perform in-process control, lot release, and stability testing using flow cytometry, qPCR, and/or cell-based assays.

Ensure proper and timely completion of testing and tasks assigned.

Report results in detailed and organized presentations and reports.

Participate in technical transfer, qualification, and validation protocols for QC assays.

Onboard new materials and reagents.

Qualifications

M.S. or B.S. degree in a scientific discipline with minimum of 5+ years of biotechnology, clinical, or pharmaceutical laboratory experience is required.

Prior experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.

Hands on experimental skills with analytical equipment qualification and maintenance.

Proficiency with aseptic techniques for working with cell culture, human blood, and blood products is desired.

Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.

Highly organized, detail oriented with excellent record keeping abilities, and computer proficiency.

Ability to work independently in a high paced team environment, to prioritize activities from multiple projects with little supervision.

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.

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 $95,000 - $115,000.

Permanent