Principal Specialist, QC Microbiology

About Allogene Therapeutics, Inc:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

About the role:

Allogene Therapeutics is seeking a highly motivated Principal Specialist in the QC Microbiology group to support the implementation of product and raw materials microbial testing program including qualification of new methods and equipment and collaborate with a cross functional team to manage microbial control strategy to maintain qualification of the classified areas for aseptic processing and manufacturing. The position will be located in Newark, California. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges.

We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.

Responsibilities include, but are not limited to:

• Lead and serve as SME for method development and qualification of microbiological methods (e.g. Sterility and Endotoxin) and equipment to support product, raw materials, environmental and utility sample testing.
• Keep current with advances related to test methods applicable to the laboratory, as well as instruments upgrades.
• Troubleshoot method and analytical instrument issues.
• Provide training for junior analysts.
• Write, review, and approve technical documents including SOPs, study protocols and reports.
• Partner with Newark Operation team to maintain and update site Contamination Control Strategy, risk assessment, and related SOP.
• Provide technical assessment to support aseptic operations and facility, and utility changes.
• Manage the generation, execution and technical review of analytical data and laboratory documents, ensuring that they are maintained in compliance with regulatory requirements.
• Contribute to continuous improvement opportunities by optimizing methods, overseeing, and coordinating re-validation, where necessary.
• Investigate 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.
• Maintain and manage critical laboratory reagents, standards and controls ensuring uninterrupted operation.
• Develop safety requirements and foster a safety culture through compliance with Health and Safety programs in place.
• Ensures QC laboratory is maintained in a constant state of compliance and is always inspection ready by conforming to all regulatory requirements and following routine 5S methodology.
• Establishes processes to trend methods performance over time
• Perform routine release and stability testing as needed
• 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 Micro methods regarding regulatory requests.
• Collaborates cross functionally and builds relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers to meet target milestones.
• Represent QC at cross-functional team or project meetings.
• 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:

• Bachelor or higher degree in Life Sciences or related field required
• Minimum 7 years of experience in Microbiology laboratory and aseptic processing in biotechnology or pharmaceutical industry required
• Strong theoretical and practical experience with various Microbiological methods - sterility, endotoxin, growth promotion, bioburden, environmental monitoring, and microbial identification
• Strong understanding of GMP requirements and QC systems (e.g, Sterility test isolators, rapid micro test systems, ID systems)
• Strong understanding and knowledge of regulatory requirements and industry guidance for Microbiological testing and aseptic processing (e.g. USP, EP, ICH, Annex 1, etc).
• Experience with method development, validation, and transfer
• Experience using/building LIMS system (i.e., MODA) and laboratory automation.
• Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings.
• Experience working with Veeva system a plus.
• Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity
• 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.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $160,000 to $180,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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