QC Analyst II

About Allogene:

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 Therapeutics is seeking a highly motivated Quality Control Analyst II/Scientist in the Quality Control Cell and Molecular Biology group to support in process, release and stability testing. The position will report to the Quality Control Sr Manager and will be located at Newark, CA with an additional reporting location in South San Francisco, CA. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.

Responsibilities include, but are not limited to:

• Performs QC analytical testing to support the release and stability of final products, with consideration of compliance, quality, and consistency.
• Review test methods data and supporting documentation.
• Maintains GMP laboratories by monitoring lab equipment and instrumentation (flow cytometers, NC-200 and support availability of lab supplies/critical reagents. Perform instrument calibration and equipment cleaning 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, with an eye for detail and open communication in reporting abnormalities.
• Documents test results to ensure completeness and accuracy per cGMP. Keeps accurate documentation and traceability.
• Support troubleshooting with minor assay performance issues and support SOP related activities as requested.
• Supports Discrepancy Management investigations and implementation of corrective and preventative actions as instructed.
• Contributes toward the development and revision of SOPs and Test Methods.
• Support method validation and transfer of QC CMB methods and critical reagent qualification by executing as instructed.
• Support Change Control by gathering and providing information necessary to support changes to existing methods.
• Draft study protocols and summary reports as needed.
• Perform non-routine laboratory tasks.
• Other duties as assigned.

Position Requirements & Experience:

• Scientific Discipline degree in Biology, Molecular Biology, or related field (or relevant experience) and 3+ years of experience in similar role in biotechnology or pharmaceutical industry is required.
• Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Demonstrated knowledge and experience in performing ELISA, Flow cytometry, cell culture and Cell-based assay.
• Must have previous working experience in aseptic technique.
• Must have experience in Flow Cytometry, cell culturing, and ELISA.
• Qualification of flow cytometry and other cell-based assay critical reagents.
• Technical protocol and report writing.
• Experience in maintenance of GMP laboratory, laboratory equipment, and instruments. 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 preferred.
• Experience of supporting troubleshooting and optimization of the method to improve the performance.
• Experience of supporting Invalid, OOE, and OOS investigation and CAPA initiation.
• Good organizational and planning skills, and an ability to work efficiently.
• 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.
• 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 20L buffer if needed as laboratory activities.
• 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 $36 to $50 an hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

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.

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