Analyst, Quality Control
Quality | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
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 world-class 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 an analyst to support routine testing and logistical activities in the QC Cell and Molecular Biology (CMB) laboratory. The incumbent will execute core laboratory testing including ELISA, Cell Culture/counting, Flow cytometry, PCR, and other related testing and will support GMP QC laboratory maintenance by managing and/or monitoring facilities, and laboratory equipment and reagents. The incumbent will perform all activities in a GMP environment by accurately following procedures, maintaining accurate and contemporaneous documentation, monitoring methods performance and reporting any deviation or discrepancy to manager. The incumbent’s duties are primarily internal, and the analyst is expected to interact with peers and management within QC and QA.
Responsibilities include, but are not limited to:
- Performs QC analytical testing to support the release and stability of intermediates, drug substance and final products for clinical and commercial use.
- Maintains compliance status of laboratories by monitoring equipment, instruments, pipettes, reagents and ensuring adherence to GMP requirements
- Maintains availability of laboratory supplies and reagents by monitoring inventories closely.
- Manages GMP and non-GMP samples chain of custody
- Performs all activities in accordance with cGMP requirements and reports discrepancies. Initiates and completes laboratory discrepancy events within expected timelines.
- Documents testing activities and results, ensuring completeness and accuracy per cGMP.
- Performs minor equipment troubleshooting, laboratory maintenance, and cleaning activities.
- Assists with troubleshooting of assay performance and supports the development, revision, maintenance, validation of SOPs
- Supports Discrepancy Management investigations and implementation of corrective and preventive actions.
- Perform non-routine laboratory tasks.
Position Requirements & Experience:
- A minimum B.S. degree in a scientific discipline with 2-4 years of experiences in an analytical development or QC environment or equivalent combination of education and experience
- Demonstrated knowledge and experience in core laboratory techniques including Cell culture, Cell-based assays, and qPCR. Immunoassay or Flow cytometry experience is plus.
- Previous working experience in aseptic techniques
- 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
- Experience supporting Invalid, OOE, and OOS investigations and CAPA initiation is plus
- Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation
- Able to learn new skills rapidly and achieve proficiency.
- Able to solve minor problems and troubleshooting as necessary
- Able to seek and receive input from senior team members for the performance of assignments as needed.
- Detail-oriented, good organizational and planning skills, and an ability to work efficiently
- Good communication skill
- 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.