Analyst II, Quality Control

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCART) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogeneis developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapyon demand, more reliably, and at greater scale to more patients.

About the role:

Allogene is seeking an Analyst II to support routine testing in the QC laboratory. Working in a GMP environment, the incumbent will execute compendial test methods (pH, Volume, appearance, Osmolality) and core laboratory testing from ELISA, Cell Culture/counting, Flow cytometry, PCR/dPCR, and other related testing. The Analyst will also support logistical activities in the lab including sample receipt and will support GMP QC laboratory maintenance by managing and/or monitoring laboratory equipment and tracking and/or qualifying reagents.

The position requires onsite presence 5 days a week at our manufacturing facility in Newark, CA.

Responsibilities include, but are not limited to:

• Performs QC analytical testing to support the release and stability of final products to support the release of products for commercial use, with consideration of compliance, quality, and consistency
• Review data package and supporting documentation.
• Maintains GMP laboratories by monitoring lab equipment, pipettes, etc. and availability of lab supply. Perform instrument calibration and equipment cleaning as needed.
• Accurately follows relevant SOPs, performs all activities in accordance with cGMP requirements reports abnormalities.
• Documents test results to ensure completeness and accuracy per cGMP. Keeps accurate documentation and tracks record.
• Support minor equipment troubleshooting, laboratory maintenance, and cleaning activities.
• Manages GMP and non-GMP samples, order and receive lab reagents and materials, and manages the inventories.
• Support ordering and qualification of critical reagents as requested.
• Support troubleshooting with minor assay performance issues and support the SOP related activities as requested.
• Support investigations and implementation of corrective and preventative actions as instructed.
• Support method validation and transfer of QC methods by executing as instructed.
• Support Change Control by gathering and providing information necessary to support changes to existing methods.
• Contributes toward the development and revision of SOPs and Test Methods.
• Perform non-routine laboratory tasks.
• Other duties as assigned.

Position Requirements &

Experience:

• A minimum B.S. degree in a scientific discipline with minimum 3 years of experiences in a cGMP compliant environment or equivalent combination of education and experience.
• Demonstrated knowledge of laboratory techniques such as Flow cytometry, ELISA, Cell culture and Cell-based assay, PCR etc.
• Must have previous working experience in aseptic technique.
• Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies. Able to perform QC laboratory maintenance related duties as assigned
• Able to follow instructions and SOPs precisely and able to make/keep accurate and contemporaneous documentation.
• Experience of supporting analytical method validation and transfer and reagent qualification.
• Experience of supporting troubleshooting and optimization of the method to improve the performance.
• Experience of supporting Invalid, OOE, and OOS investigation and CAPA initiation.
• Able to solve minor problems and troubleshoot, as necessary.
• Good organizational and planning skills, and an ability to work efficiently.
• Able to…