Analyst II, QC Cell and Molecular Biology (Contract)
Quality | South San Francisco, CA | Contract
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Contract Analyst II to support routine testing and logistical activities in the QC Cell and Molecular Biology (CMB) laboratory. Working in a GMP environment, you will execute compendial test methods (pH, Volume, appearance, Osmolality) and core laboratory testing from ELISA, Cell Culture/counting, Flow cytometry, PCR, 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 facilities, and laboratory equipment and reagents. This position reports into our Associate Director, Quality Control and is based out of our headquarters in South San Francisco, CA. This is a 9-month contract position.
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 test methods data 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.
- 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.
- 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 troubleshooting with minor assay performance issue and support the SOP related activities as requested
- Supports Discrepancy Management investigations and implementation of corrective and preventative actions as instructed
- Contributes toward the development and revision of SOPs and Test Methods.
- Support method validation and transfer of QC CMB methods and critical reagent qualification by executing as instructed.
- Support Change Control by gathering and providing information necessary to support simple changes to existing 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 ELISA, Cell culture and Cell-based assay, PCR, Flow cytometry, etc.
- Must have previous working experience in aseptic technique.
- Must have extensive experience in qPCR assay. Additional experience in Flow Cytometry or Cell-based assay is plus.
- 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.
- 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 business requirements in a dynamic corporate environment.
- Good communication skill. Able to maintain good interaction with peers and leadership within Quality Control
- Physically able to lift LN2 freezer rack or move up to 20L buffer if needed as laboratory activities.
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.