Specialist, Quality Control
Quality | South San Francisco, 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 QC Specialist to provide scientific technical expertise to the QC Cell and Molecular Biology (CMB) laboratory. The incumbent will act as Subject matter Expert (SME) for Cell based-assays, qPCR methods, and Immunoassay and will be responsible for the review and approval of test records and documentation generated from the CMB laboratory and other CROs as needed. The incumbent will support daily laboratory operations, including scheduling, training, and troubleshooting and will perform laboratory testing as needed to ensure all operations are completed within timeline. He or she will support deviation investigations, CAPA initiation and completion, and method-related change management as needed. The incumbent’s duties are mostly internal within Allogene but may support external test method and data review as needed.
Responsibilities include, but are not limited to:
- Serves as a Subject Matter Expert (SME) for QC CMB test methods for cell-based assays, qPCR, and Immunoassays.
- Monitors assay performance and troubleshoots and improves existing methods as needed and optimizes efficiency. Leads method validation and transfer of QC CMB methods and critical reagent qualification as needed.
- Reviews and approves test records and documentation generated from the CMB laboratory and other CROs using scientific principles, evaluates data, and interprets trends as needed.
- Supports Associate Director by assisting in laboratory operations, including scheduling, training and troubleshooting to ensure all operations are in full compliance with applicable SOPs and safety guidelines. May performs QC analytical testing to support the release and stability of final products when needed.
- Demonstrates expertise of operating, maintenance and troubleshooting skills for instruments as well as quality and regulatory requirements pertinent to quality control labs.
- Performs moderate to complex equipment troubleshooting.
- Supports laboratory maintenance and cleaning activities are performed in timely manner.
- Maintains and qualifies critical reagents and assay standard and control. Monitor assay performance based on system suitability and assay control acceptability and escalates any issue.
- Supports the team’s responsibilities for the performance of all testing and/or for regulatory requirements pertinent to quality control lab.
- Supports transfer and validation of methods from other departments or CROs within timeline. Writes or reviews transfer/validation protocol or report.
- Performs technical investigations of discrepancies, OOS, and Unexpected results and supports the implementation of corrective and preventative actions with consideration of compliance, quality, and consistency.
- Performs assay training, manages multiple tasks concurrently and effectively. Perform non-routine laboratory tasks.
- Assists with addressing questions during regulatory compliance audits and supports inspection-related needs as required.
- May interacts with regulatory agencies, customers and internal auditors/inspectors. Supports positive employee relations climate.
Position Requirements & Experience:
- BS/BA degree in a scientific discipline with 8+ years of experience performing relevant activities including working in a cGMP compliant environment or equivalent education/training.
- Broad knowledge and experience performing “core” laboratory techniques: Must have extensive experiences in Cell culture, Cell-based assay, and qPCR assay. FACS or Immunoassay experience is plus.
- Experience or working knowledge of analytical method development, validation, and transfer and reagent qualification and maintenance.
- Thorough understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP.
- Ability to detect any issue in the assay performance and troubleshoot and optimize the method to improve the performance.
- Experience of Invalid, OOE, and OOS investigation and CAPA initiation
- Previous experience in regulatory compliance audits and inspection-related supports.
- Ability to solve problems of moderate to complex level and troubleshoot as necessary
- Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment. Able to learn new skills or software rapidly and achieve proficiency.
- Highly detail-oriented team player with a strong interpersonal skill with good verbal and written communication skills. Good organizational and planning skills, good writing skill, and an ability to work efficiently. Able to enjoy a fast-paced, team-oriented, and collaborative environment.
- Proficient in Microsoft Office Suite and Statistical software.
- 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. 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.