Analyst II, Quality Control

Allogene Therapeutics•Newark, NJ

3d•Onsite

About The Position

Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T cell therapies for cancer and autoimmune diseases. They are seeking an Analyst II to support routine testing in their Quality Control (QC) laboratory. This role involves executing compendial test methods and various laboratory tests including ELISA, cell culture, flow cytometry, and PCR in a GMP environment. The Analyst will also manage logistical tasks like sample receipt, equipment maintenance, and reagent inventory. The position requires a 5-day onsite presence at their manufacturing facility in Newark, CA.

Requirements

A minimum B.S. degree in a scientific discipline.
Minimum 3 years of experience 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.
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 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.

Responsibilities

Performs QC analytical testing to support the release and stability of final products for commercial use, ensuring compliance, quality, and consistency.
Reviews data packages and supporting documentation.
Maintains GMP laboratories by monitoring lab equipment, pipettes, and ensuring availability of lab supplies.
Performs instrument calibration and equipment cleaning as needed.
Accurately follows relevant SOPs and performs all activities in accordance with cGMP requirements, reporting abnormalities.
Documents test results to ensure completeness and accuracy per cGMP.
Keeps accurate documentation and tracks records.
Supports minor equipment troubleshooting, laboratory maintenance, and cleaning activities.
Manages GMP and non-GMP samples, orders and receives lab reagents and materials, and manages inventories.
Supports ordering and qualification of critical reagents as requested.
Supports troubleshooting with minor assay performance issues and supports SOP-related activities.
Supports investigations and implementation of corrective and preventative actions as instructed.
Supports method validation and transfer of QC methods by executing as instructed.
Supports 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.
Performs non-routine laboratory tasks.
Other duties as assigned.