Senior Analyst, QC Environmental Monitoring and Microbiology
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
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 world-class 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 Sr. Analyst to support routine and non-routine GMP microbiological sampling, including environmental monitoring (EM) of classified clean rooms and critical utilities (RODI, Clean Steam, Clean Dry Air), release of product, and testing for validation protocols. Coordinates testing performed by contract laboratories as needed. Reads and interprets microbiological cultures and other related tests including, but not limited to, environmental monitoring, bioburden tests, growth promotion, endotoxin (LAL), and TOC testing. Writes and executes protocols to perform validation, technology transfer and troubleshooting for microbiology testing. Writes standard operating procedures (SOPs) for the QC EM/Microbiology labs. Reviews environmental monitoring data and laboratory equipment documentation and records. Prepares EM trend reports and work with cross functional team to resolve trend issues. Performs and receives training on microbiological methods. Interacts with Facilities, Manufacturing and QA as needed to coordinate testing and support investigations of EM and microbiological excursions. Works with contract laboratories and equipment vendors as needed. Support Laboratory IT Systems (MODA/LIMS) implementation plan.
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. The incumbent may oversee EM/Micro testing at contract organizations.
Responsibilities include, but are not limited to:
- Performs EM /Micro QC sampling and testing to support the release of utilities, facility and product
- Support implementation of EM IT System (MODA) and LIMS
- Maintains compliance status of laboratories by monitoring equipment, instruments, EM plates, reagents and ensuring adherence to GMP requirements
- Maintains availability of laboratory supplies EM plates, media, reagents by monitoring inventories closely.
- Manages EM and Utility sampling and testing schedule and chain of custody of samples
- 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 aseptic techniques training and oversee
- 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, Facility & Engineering, and Manufacturing).
Position Requirements & Experience:
- A minimum B.S. degree in a scientific discipline with 4-7 years of experiences in a cGMP compliant environment or equivalent combination of education and experience
- Demonstrated knowledge in “core” laboratory techniques including aseptic techniques, EM sampling and testing, LAL, Bioburden, Growth Promotion, TOC, etc.
- Previous working experience in aseptic techniques and EM/Microbiological methods is required
- 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, EM trend reports, and validation protocols
- Experience with EM System- MODA is plus
- 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 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.