Associate Director, Process and Product Development

About Allogene:

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 is seeking an Associate Director, Process and Product Development to lead the Drug Product Team for Allogene’s CAR-T cell therapies. This individual will lead the development, characterization and implementation of state-of-the-art formulation, aseptic filling, and cryopreservation drug product processing technologies to deliver scalable and robust clinical and commercial manufacturing processes. This position will also lead successful tech transfer and SME support for GMP clinical and commercial drug product manufacturing.

Responsibilities include, but are not limited to:

• Manage, lead and mentor a high performing team of scientists and provide oversight and technical leadership for the development of formulation, aseptic filling, cryopreservation, drug product container, storage, and post thaw processes and procedures
• Develop robust processes for formulation, fill/finish, and cryopreservation for chimeric antigen receptor T-cell (CAR-T) products utilizing QbD DOE principles
• Establish and qualify representative fill/finish scale-down models to identify CPPs that impact Drug Product CQAs
• Collaborate with CMC and clinical teams to evaluate dosage form options to enable dosing requirements for in-use dosing and administration stability studies and other TPP objectives
• Use risk assessment/management tools and apply QbD principles for successful technology and knowledge transfer to internal and external Drug Product manufacturing sites
• Lead and facilitate cross-functional activities in support of pipeline priorities by working collaboratively across CAR-T Process Sciences, Analytical Development, Internal/External Manufacturing, Quality, and Regulatory groups
• Drive and coordinate studies while managing timelines to meet corporate goals
• Implement process advancements for scaling-up and introduction into a GMP manufacturing environment
• Act as internal expert and maintain state-of-the-art knowledge in the field of cellular cryopreservation and cryobiology
• Other duties as assigned

Position Requirements & Experience:

• Ph.D. in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field or equivalent experience
• Relevant experience in the pharmaceutical/biotech industry
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding)
• Strong knowledge and hands-on experience with cell therapy process development and cryopreservation
• Formulation science experience, especially with cryoprotectant additives
• Strong scientific understanding of cell biology and cryopreservation
• Experience working in or supporting a cGMP-regulated environment
• Experience in cell therapy manufacturing processes
• Ability to work in a fast-paced, startup environment
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Experienced leader of scientific teams
• Experienced project management/leadership skills
• 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 $170,000 to $210,000. 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.

Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.

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