Analyst I, QC Sample Management
Quality | Newark, CA | Full Time
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 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 a motivated candidate as a QC Analyst I to join and support Sample Management Office (SMO) and Stability Group in the Quality Control Department within the Quality organization. The Sample Management Group manages and stores final drug product, in-process, and raw materials. You will lead and oversee sample management workflows and contribute to the broader state of the art facility for storage and distribution of biologic samples within internal and external CMOs/CTL partnering sites. You will also handle protein samples distribution, management, and process assessments and logistic improvements and act as the primary point of contact for biological sample logistics and deliverables. You will support logistical activities in the sample management office and stability labs including sample receipt and will support GMP QC laboratory maintenance by managing and/or monitoring facilities, and laboratory equipment. You will perform all activities in a GMP environment by accurately following procedures, maintaining accurate and contemporaneous documentation and reporting any deviation or discrepancy to manager.
This hands-on position reports to our Senior Manager, Quality Control, Stability & Controls and is based out of our Newark, CA manufacturing facility.
Responsibilities include, but are not limited to:
- Performs QC sample distribution to support release and stability testing of in-process and final products to support the release of products for commercial use, with consideration to compliance, quality, and consistency.
- Manages GMP and non-GMP sample receipt, storage, sample log in, sample packing/unpacking, sample delivery, inventory tracking, coordinate shipping activities, fulfill requests for samples, monitor sample chain of custody, reconcile documentations and sample label against sample shipments, and resolve any discrepancies and sample associated data for presentation and workflows.
- Coordinate stability sample analysis internally and externally with CMO/CTLs and data transfer to manager.
- Maintain Sample Management Office and Stability laboratories in GMP readiness state and cleaning activities per SOPs.
- Ensure Temperature Controlled Units are within calibration date.
- Ensure timely shipment to internal departments, external CTLs or external storage sites.
- Accurately follows relevant SOPs, perform activities in accordance with cGMP requirements and report abnormalities.
- Keep accurate documentation, track samples in laboratory logbooks and perform non-routine laboratory tasks.
Position Requirements & Experience:
- A minimum B.S. degree in a scientific discipline with minimum 1 year of experiences in a cGMP compliant environment or equivalent combination of education and experience.
- Experience in GMP/GxP environment is required.
- Prior experience in biologics sample management is desired.
- Successful candidate will have the following attributes: highly organized, motivated, proactive, work independently in a collaborate team-oriented setting and demonstrate organization leadership and communication skills.
- 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.