Allogene is looking for a seasoned, broadly trained Manager/Sr. Manager to manage the Quality Control (QC) Cell and Molecular Biology (CMB) laboratory operations at Newark site supporting the CAR T products’ clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization, and qualification capability in the allogeneic cell therapy space. The incumbent will support the QC CMB Associate Director to meet the department goals and ensure the CMB laboratory’s streamlined operations, including scheduling, training, testing, and troubleshooting. This incumbent will lead QC test method improvement and validation and may perform the execution as needed. He or she will support deviation investigations, CAPA initiation and completion, and method-related change management as needed. The role requires the ability to operate in a fast-paced, highly dynamic environment.
Responsibilities include but are not limited to:
- Supports Associate Director of QC Cell and Molecular Biology to lead the CMB laboratory operation related release and stability testing, ongoing development and validation activities, establishing/meeting timelines, ensuring that the departmental goals and metrics are met.
- Provides effective leadership to manage direct reports including goal setting, performance reviews, employee evaluations, employee carrier development, appreciation of employee contributions, mitigation of conflicts and timely communication of issues to senior management.
- Maintains the cGMP compliant status of the lab and team activities and ensure the safety of all team members.
- Ensure all testing is completed within TAT
- Monitors assay performance and troubleshoots and improves existing methods as needed and optimizes efficiency.
- Provides technical support on QC CMB test methods including Flow cytometry, cell-based assay, and/or qPCR as needed.
- Owns and executes change management, deviation investigations and CAPA initiations and implementation in a timely manner.
- Manages the generation, execution and technical review of analytical data and laboratory documents ensuring that they are compliant with FDA regulations and Allogene internal directives.
- Manages method validation and transfer of QC CMB methods and critical reagent qualifications.
- Establishes/maintains streamlined laboratory operations with optimizing workload and resources. Contributes to continuous improvement and simplification of lab operations.
- Maintains sound collaborative relationships within the QC department and cross-functional groups, specifically with QA and Analytical Development.
- Ensures direct reports are properly trained and adhere to their training plans.
- Assumes the responsibility as the system owner for laboratory-related activities and cGMP compliance maintenance.
- May interact with regulatory agencies and internal auditors/inspectors as needed. Supports regulatory filings with documentation, as needed.
Position Requirements & Experience:
- Minimum of 7+ years for BS, 5+ years for MS, 3+ years for PhD in analytical development/QC laboratory experience in Cell Biology, Molecular Biology, or Immunology.
- Minimum of 1+ years of a QC cGMP lab management experience required.
- Sr. Manager:
- Minimum of 9+ years for BS, 7+ years for MS, 5+ years for PhD in analytical development/QC laboratory experience in Cell Biology, Molecular Biology, or Immunology.
- Minimum of 3+ years of a QC cGMP lab management experience required.
- Extensive knowledge of QC analytical testing supporting Cell Therapy products such as Flow Cytometry, Cell-based potency assay, Cell Counting, ELISA, qPCR/RT-PCR, etc.
- Extensive knowledge in life cycle management of QC methods including method development, validation, and transfer and reagent qualification and maintenance.
- Strong understanding and experience of GMP requirements and QC systems
- Experience in dealing with regulatory agencies, supporting GMP inspections as well as experience with regulatory filings.
- Experience of Change Management, Invalid, OOE, and OOS investigation, deviation initiation/investigation, and CAPA initiation
- Strong leadership abilities and effective communication and influencing skills required.
- Highly collaborative with the proven ability to work effectively in a cross-functional team.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong interpersonal skills including verbal and written communication are essential.
- Able to embrace a fast-paced, team-oriented, and collaborative environment.
- Candidates must be authorized to work in the U.S.