Senior Analyst, QC Cell and Molecular Biology
Quality | Newark, 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 Sr. Analyst to support routine testing and logistical activities in the QC Cell and Molecular Biology (CMB) laboratory. The incumbent will execute core laboratory testing with a primary focus on Flow cytometry but not limited to ELISA assays and cell culturing processes. The incumbent will support related testing and 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 predominantly internal, and the analyst is expected to interact with peers and management within QC and QA as well as other cross functional team members from Process/Analytical Development. The incumbent may oversee testing at contract organizations. Initially the role will be based in our South San Francisco office for training for 3+ months, and then will be based out of the Newark manufacturing site.
Responsibilities include, but are not limited to:
- Strong working knowledge of flow cytometry for routine testing, method validation and method transfer processes.
- 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.
- Demonstrates hands-on knowledge of operation, maintenance and troubleshooting of instruments as well as GMP requirements pertinent to quality control labs.
- Performs easy to moderate equipment troubleshooting as needed.
- Drives laboratory maintenance and 5S activities.
- Supports Discrepancy Management investigations and implementation of corrective and preventive actions.
- Performs assay training and supports qualification of junior analysts.
- Assists and troubleshoots with assay performance.
- Contributes toward the development, revision, application, maintenance, validation and review of methods SOPs. Initiates and follows up on change request for SOP revisions.
- Assists with addressing questions during GMP audits and supports inspection-related needs as required.
- Manages multiple tasks concurrently and effectively.
- Maintains working relationships with peers, department management, and other departments (e.g, QA, Process/Analytical Development, Manufacturing).
Position Requirements & Experience:
- A minimum B.S. degree in a scientific discipline with 6+ years of experiences in a cGMP compliant environment or equivalent combination of education and experience
- Demonstrated knowledge in “core” laboratory techniques including ELISA, Cell culture and Cell-based assay, Flow cytometry, and other molecular biology technologies
- Previous working experience in aseptic techniques or in flow cytometry is required.
- Extensive 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
- Experience authoring SOPs
- Experience with change management process
- Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation
- Able to learn new skills rapidly and achieve proficiency. Detail-oriented with good written and verbal communication skills
- Able to seek and receive input from senior team members for the performance of assignments as needed.
- Ability to solve problems of moderate complexity and troubleshooting as necessary
- Good writing skill, Good organizational and planning skills, and an ability to work efficiently
- Team player with good interpersonal skills
- 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.