Lead Cell Therapy Specialist

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 manage the manufacturing and release of cell therapy products, ensuring compliance with cGMP regulations and supporting operational readiness and technology transfer.

You Will:

• Manage and execute 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 escalate issues.
• Maintain cleanroom standards, including managing 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.

You Have:

• 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 proven ability to identify, analyze, and solve problems effectively.
• Ability to foster innovation, collaboration, and team effectiveness.
• Skilled in making timely decisions and understanding when to escalate or delegate tasks.

Preferred Qualifications:

• 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.

The annual base salary for this position ranges from $81,992.80 to $122,989.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

• 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.

#celltherapy #LI-Onsite

Date Posted
17-Apr-2025

Closing Date
29-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.