Associate Director/Dir, Chemistry and Raw Materials Management
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 leader to oversee the implementation of a Raw Materials (RM) QC Management programs and the operation of the Chemistry/Biochemistry Quality Control (QC) laboratories supporting 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 head of QC in defining the strategy for the design and build out of the new Chemistry/Biochemistry QC laboratory and will be responsible for the timely implementation/validation of QC methods according to plan and budget. The candidate will also be responsible for the Raw Materials inspection/testing programs at Allogene and external laboratories. The candidate will support the QC head in defining laboratory systems and processes for the compliant operation of the new QC laboratories. The role will be responsible for hiring and training laboratory analysts and RM inspectors, and ensuring their readiness for GMP testing/operation. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders.
Responsibilities include, but are not limited to:
- Contributes to the strategic vision and design of the Chemistry/Biochemistry QC laboratories build out project as well as the RM inspection/testing /vendor qualification programs ensuring project timelines and budget are met.
- In collaboration with QA and Process and Analytical Development, supports the Allogene RM program to create phase appropriate RM specifications and qualify vendors.
- In collaboration with AD External Testing Oversight, responsible for establishing/overseeing RM testing at external laboratories.
- Responsible for the overall strategy, direction, oversight, planning, implementation and day to day operation of the RM inspection program and Chemistry/Biochemistry QC laboratories ensuring the compliant testing of raw materials, in process, drug substance and drug product for release and stability within agreed upon turn-around time (TAT).
- Responsible for technical decisions associated with the laboratory operations and projects as well as managing the generation, execution and technical review of analytical data and laboratory documents, ensuring that they are maintained in compliance with regulatory requirements.
- Serves as SME and qualifies on all methods utilized within the Chemistry/Biochemistry group. Keeps current with advances related to test methods applicable to the laboratory, as well as instruments upgrades. Contributes to continuous improvement opportunities by optimizing methods, overseeing and coordinating re-validation, where necessary. Troubleshoots methods and analytical instrumentation
- Recruits and develops team members to meet the requirements of a QC organization. Defines procedures for the training and qualification of analysts and ensures that all are trained and qualified accordingly.
- Ensures safety of all team members by enforcing compliance with Health and Safety programs in place.
- Responsible for the timely execution of methods optimization as needed, transfers and validations in alignment with AD/Director Infrastructure Support and Methods Life Cycle
- Ensures QC laboratory is maintained in a constant state of compliance and is inspection ready at all time by conforming to all regulatory requirements and following routine 5S methodology.
- In collaboration with Manufacturing and Supply Chain, establishes TAT for testing. Implements appropriate systems and processes in the laboratory to schedule and complete testing within agreed upon TAT.
- Supports the implementation of an ELN and LIMS systems and other computerized systems as needed
- Investigates invalid events, unexpected/Out of Trend and Out of Specifications test results; writes investigation/test plans and completes reports when applicable. Collaborates effectively with QC partners and QA representatives to manage the initiation, investigation, and closure of deviation/incident reports as well as CAPA implementation.
- Responsible for the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation
- Establishes processes to trend methods performance over time
- Provides technical guidance to external contract laboratories as needed
- Interacts with internal auditors/external inspectors from regulatory agencies
- As needed, author and review technical registration documents and submissions to regulatory agencies as well as serve as SME for the Chemistry/Biochemistry methods regarding regulatory requests.
- Actively manages laboratory operations costs and ensures compliance with the Quality Unit budget goals.
- Collaborates cross functionally and builds relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers to meet target milestones.
- Manages multiple projects, set priorities, and work in a fast-paced environment.
- Able to negotiate, influence, and work in a matrix environment.
- Other duties as assigned
Position Requirements & Experience:
- Ph.D. preferred, M.S./B.S. Degree considered
- Minimum 8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role.
- Strong theoretical and practical experience with various chromatography techniques/instrumentation, capillary electrophoresis (CE), gel electrophoresis/western blot analyses, wet chemistry methods, and ELISA/HTRF,
- Strong understanding of GMP requirements and QC systems
- Experience with method development, validation and transfer
- Experience using/building LIMS system and laboratory automation.
- Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings.
- Strong leadership ability, interpersonal, communication, and influencing skills required.
- Highly collaborative with the proven ability to work 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 in this collaborative work environment.
- 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.