Senior Analyst, QC Cell and Molecular Biology (Contract)

Allogene Therapeutics•Newark, NJ

6d•Onsite

About The Position

About Allogene: 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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: Allogene is seeking a highly self-motivated Senior Analyst to support routine testing and logistical activities in the QC laboratory in a fast-paced environment. The incumbent will execute core laboratory testing including qPCR, ddPCR, ELISA, potency, mammalian cell culture, flow cytometry, 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. This is a 6-month contract opportunity and is based out of our Newark, CA location. An extension will be considered.

Requirements

A minimum B.S. degree in a scientific discipline with 4+ years of experiences in a cGMP compliant environment or equivalent combination of education and experience
Demonstrated knowledge in “core” laboratory techniques including PCR, ddPCR, Flow cytometry and other cell/ molecular biology technologies.
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 skills, organizational and planning skills, and the ability to work efficiently
Team player with good interpersonal skills
Candidates must be authorized to work in the U.S.

Responsibilities

Performs QC analytical testing to support the release and stability of intermediates, drug substance and final products for clinical and commercial use.
Collaborate with crossfunctional teams to validate and troubleshoot PCR assays, interpret results using various software and spreadsheets for accurate reporting.
Perform end-to-end PCR workflows, including sample preparation, nucleic acid extraction, amplification, and post-PCR analysis, ensuring high accuracy and reproducibility.
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).