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 business requirements in a dynamic corporate environment.
- Good communication skills. Able to maintain good interaction with peers and leadership within Quality Control
- Physically able to lift LN2 freezer rack or move up to 15 lbs.
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $ per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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