Analyst II, Global Quality Control
Quality | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
About the role:
Allogene is seeking a QC Analyst II to support routine testing and logistical activities in the Global QC laboratory. The candidate will execute core laboratory testing including but not limited to PCR and ddPCR, flow cytometry, ELISA, cell culture/counting, compendial test methods (pH, Volume, appearance, Osmolality). There will be opportunities for the analyst to support methods optimization, qualification and validation activities. The candidate is expected to support logistical activities in the lab including sample management and will support GMP QC laboratory maintenance by managing and/or monitoring facilities, and laboratory equipment and reagents. The candidate 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 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 final drug products for clinical and 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/equipment cleaning per the schedule and support calibrations 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 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 of minor assay performance issues.
- Supports discrepancy management investigations and implementation of corrective and preventative actions as required.
- Contributes toward the development and revision of SOPs and Test Methods.
- Support method optimization, validation and transfer of Global QC methods and critical reagent qualification.
- Maintains working relationships with peers, department management, and other departments (e.g., QA, Process/Analytical Development, Manufacturing).
- Perform non-routine laboratory tasks.
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 in most of “core” laboratory techniques (e.g. ELISA, cell culture and cell-based assays, PCR and ddPCR, Flow cytometry, etc.)
- Must have previous working experience in aseptic technique
- Should have extensive experience in cell-based assays, qPCR, flow cytometry and/or Immunoassays
- 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 in supporting analytical method validations and transfers, reagent qualification, and method lifecycle management
- Report issues related to assay performance and support troubleshoot and optimization of the method to improve performance
- Support Invalid, OOE, and OOS investigations and CAPA initiations
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Maintain good interaction with subordinates, peers and leadership within the quality organization
- 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
- Ability to work independently and as part of a team
- Physically able to lift LN2 freezer racks or move up to 20L buffers if needed as laboratory activities
- Candidates must be authorized to work in the U.S
As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.