Associate Scientist, Quality Control Lab Operations
San Diego, CA
Regulatory & Quality – Quality Control /
Exempt Full-time /
On-site
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.
