Analyst II, Quality Control at Allogene Therapeutics in Newark, CA

Job description

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on 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 learn new skills rapidly and achieve proficiency as necessary. Able to seek and accept input from more senior team members for the performance of assignments as needed. Able to multi-task and adapt to changing busi