Allogene is seeking a Product Quality Leader (PQL) to oversee Allogene’s CAR T programs and / or antibody program. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The role will entail oversight and coordination of QC related activities associated with drug substance/drug product manufacturing internally or at contract manufacturing organizations (CMO) for clinical and future commercial use, including but not limited to testing, stability studies, standards and controls, discrepancies/Out Of Specifications (OOS)/CAPA management, and comparability studies. The individual will be responsible for providing analytical expertise and technical oversight supporting method validations, product characterization and process qualification activities. As the representative of the QC organization on CMC teams, the individual is expected to provide strategic input to support the product development program throughout clinical development in preparation for commercial launch. The individual will be responsible for authoring/reviewing, the revision and maintenance of technical registration documents associated with areas of focus. This position reports into the QC organization.
Responsibilities include, but are not limited to:
- Supports the formulation of the product control strategy and overall design of stability studies in alignment with the Process and Product Development teams and Quality management.
- Drives the development of product specifications and associated justifications.
- Defines bridging strategies for the implementation of new analytical methods during the course of the product development life cycle, ensuring sound scientific rationales are applied.
- In collaboration with QC management and/or contract testing organizations, defines methodologies to evaluate performance and trending of analytical methods. Partners with Quality Engineering to define appropriate statistical tools as needed. Evaluates data with respect to potential product impact.
- Escalates, as needed, to QC and QA heads in event of unexpected and OOS results. Provides recommendation on proposed path(s) forward and investigation approach.
- Represents QC on CMC teams responsible for product development and manufacturing, internally or at CMO.
- Demonstrates the ability to translate complex process knowledge and understanding into robust implementation plans for product/program changes.
- Applies quality and process knowledge to support product transition from clinical to commercial, new product introductions and tech transfers.
- Supports comparability study strategies and design to address material changes and process changes due to process scale up and/or capacity expansion. Partners with Quality Validation and Manufacturing to define parameters for process qualification.
- Provides guidance and direction to address root cause of discrepancies and to define corresponding CAPA. Serves as QC point person for OOS management and CAPA implementation at contract organizations.
- Oversees the authoring, reviews and revisions of technical registration documents and submissions to regulatory agencies. Partners and aligns with QC management and/or contract organizations on content of submissions. Partners with Regulatory Affairs and Quality to address responses to regulatory requests and comments. Supports Annual Product Review submissions.
- Ensures conformance to all regulatory requirements, including FDA and various international regulatory governmental bodies. Interacts directly with auditors/inspectors in support of PAI and GMP inspections.
- Represents the QC function on due diligence and external sites inspection activities.
- Collaborates with internal and external stakeholders to drive company objectives, to resolve issues and define escalation mechanisms, while ensuring team meets quality and compliance requirements.
- Engages in external technical forums to advance Allogene’s internal capabilities and influence external current positions.
- Exhibits the capacity to communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
- Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
- Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
- Other duties as assigned
Position Requirements & Experience:
- Ph.D. degree in life Sciences with a minimum of 7-10 years of experience in the biotechnology. Equivalent combination of education and experience considered.
- Practical knowledge and solid understanding of biological drug development process from early development to product launch and support of commercial products. Process validation experience is a plus.
- Sound knowledge of cGMP and regulatory compliance (US and other international agencies). Proven track record of successfully managing PAI and/or GMP inspections.
- Experience with analytical and biologicals methods development, optimization and validation, as well as stability programs.
- Strong knowledge of statistics and working experience with statistical and trending software such as JMP.
- Experience in managing and investigating deviations and CAPA implementation.
- Experience in dealing with regulatory agencies supporting regulatory filings.
- Experience with project management in a matrix organization.
- Strong leadership ability, interpersonal, communication, and influencing skills required.
- Candidates must be authorized to work in the U.S.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.