Lead Cell Therapy Specialist

AstraZeneca • Los Angeles, CA

1d • Onsite

About The Position

We are looking for a Lead Specialist in Manufacturing to join our team in Tarzana, CA, focusing on TCR-T, CAR-T, and allogeneic platforms. This role may involve travel between Tarzana and Santa Monica, CA, and reports directly to the Associate Director of Manufacturing, NGF70. As the Lead Specialist, you will handle the manufacturing and release of cell therapy products, ensuring compliance with cGMP regulations and supporting operational readiness and technology transfer. You Will: Lead and implement on-floor production activities for all manufacturing runs at NGF70, providing training for personnel in cGMP principles and aseptic techniques. Oversee GMP production activities, ensuring operations meet appropriate controls and troubleshoot or advance issues. Maintain cleanroom standards, including handling material and consumable inventories, equipment cleaning, and conducting monthly self-inspections. Perform testing during manufacturing runs, including cell counts, hemocytometer analysis, and flow cytometry, ensuring compliance with cGMP. Support technology transfer activities for GMP readiness in clinical manufacturing at NGF70, collaborating with Manufacturing Science and Technology (MSAT), Process Development (PD), and Facilities and Engineering (F&E). Develop and implement Standard Operating Procedures (SOPs) for new and updated manufacturing processes. Lead quality record investigations, ensuring documentation completion and the implementation of corrective and preventive actions. Identify opportunities for personnel development and communicate improvement needs to manufacturing leadership. Undertake additional responsibilities and projects as assigned to meet business needs.

Requirements

• High School Diploma with 5 years of experience or a bachelor’s degree with 3 years in the cell therapy, pharmaceutical, or biotech industries, demonstrating increasing responsibility.
• Experience with cGMP processes and aseptic techniques for cell culture and single-use technologies.
• Direct experience with technology transfer and GMP clinical/commercial manufacturing operations.
• Excellent organizational, communication, and interpersonal skills.
• Strong work ethic with a confirmed ability to identify, analyze, and solve problems effectively.
• Ability to champion innovation, collaboration, and team effectiveness.
• Skilled in making timely decisions and understanding when to escalate or delegate tasks

Nice To Haves

• Previous experience in people management.
• Proficient in applying principles and practices related to the role.
• Capable of independently developing solutions to complex problems, referring to established procedures.
• Ability to work with minimal direction while setting objectives and plan activities for both individuals and teams

Responsibilities

• Lead and implement on-floor production activities for all manufacturing runs at NGF70, providing training for personnel in cGMP principles and aseptic techniques.
• Oversee GMP production activities, ensuring operations meet appropriate controls and troubleshoot or advance issues.
• Maintain cleanroom standards, including handling material and consumable inventories, equipment cleaning, and conducting monthly self-inspections.
• Perform testing during manufacturing runs, including cell counts, hemocytometer analysis, and flow cytometry, ensuring compliance with cGMP.
• Support technology transfer activities for GMP readiness in clinical manufacturing at NGF70, collaborating with Manufacturing Science and Technology (MSAT), Process Development (PD), and Facilities and Engineering (F&E).
• Develop and implement Standard Operating Procedures (SOPs) for new and updated manufacturing processes.
• Lead quality record investigations, ensuring documentation completion and the implementation of corrective and preventive actions.
• Identify opportunities for personnel development and communicate improvement needs to manufacturing leadership.
• Undertake additional responsibilities and projects as assigned to meet business needs.

Benefits

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
• Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED