Associate Scientist, Quality Control
Fatetherapeutics · San Diego, CA · onsite
Responsibilities:
- Perform in-process control, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based potency assays.
- Execute processes that support sample receipt and processing for release/stability samples for testing and retains.
- Ensure accurate, timely, and compliant execution of assigned testing, laboratory activities, and project deliverables in accordance with approved procedures and applicable quality requirements.
- Draft, revise, and maintain analytical test methods or equipment SOPs, raw material specifications, and/or sampling plans.
- Collaborate cross-functionally to support new product introduction, analytical method development and optimization, and method qualification or validation activities.
- Participate and lead cross-functional training efforts.
- Support the execution, documentation, and resolution of laboratory investigations, deviations, CAPAs, and other quality events through scientific evaluation, data analysis, and root cause assessment.
- Identify, recommend, and implement continuous improvement opportunities to enhance QC laboratory processes, analytical performance, data quality, and operational efficiency.
- Onboard and support validation, qualification, and maintenance of new equipment, partnering with Facilities to complete and maintain equipment lifecycle documentation.
- Assist with the implementation, optimization, and troubleshooting of analytical methodologies and associated instrumentation, particularly molecular assays and nucleic acid extraction workflows.
- Participate in technical transfer, qualification, and validation protocols for QC assays including protocol execution, data analysis and documentation.
- Onboard new materials and reagents and track qualification of reagents and assay controls.
- Perform technical review of analytical data and associated documentation to ensure accuracy, completeness, traceability, and compliance with applicable procedures and quality standards.
- Maintain laboratory readiness through routine laboratory upkeep, including inventory management, reagent and consumable organization, equipment readiness, and general housekeeping in accordance with applicable safety and quality requirements.
- Apply critical thinking, sound scientific judgment, and a data-driven approach to troubleshoot assay performance, evaluate unexpected results, and support timely resolution of laboratory and quality issues.
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 qPCR, ddPCR is required, additional competency in flow cytometry, ELISA or cell-based assays is preferred.
- 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 & Physical Requirements:
- 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.
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 $105,000 - $115,000.
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 Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
⚠️ Recruitment Fraud Alert
Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.
- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
- We will only ask for personal information when applying for a position via our Careers page or thereafter.
- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.
- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.
Please exercise caution. If something feels off about your interactions, we encourage you to contact us at careers@fatetherapeutics.com to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.