Cell Therapy GMP Manufacturing Specialist

AstraZeneca GmbH; Santa Monica (CA); On-site; USD 68,000 - 103,000; Full time

Job summary

AstraZeneca GmbH in Santa Monica, CA is hiring a Manufacturing Specialist, Cell Therapy to independently execute GMP manufacturing for TCR T, CAR T, and allogeneic cell therapy products. You will ensure quality, readiness, and accurate documentation while supporting technology transfer and continuous improvement.

The role requires strong aseptic technique, cGMP knowledge, and experience with batch records. You will mentor associates, uphold cleanroom standards, and collaborate across functions

Qualifications

• High School Diploma with at least 2 years of relevant experience in science, engineering, life sciences, or related discipline.
• Knowledge of cGMP processes, SOPs, batch records, and quality systems.
• Aseptic technique, cleanroom behavior, contamination control, and GMP documentation practices.
• Experience supporting GMP clinical manufacturing, technology transfer, process implementation, or regulated manufacturing execution.
• Ability to develop solutions to routine and moderately complex problems using established procedures and sound judgment.
• Ability to plan and organize assigned work with limited supervision.
• Strong written and verbal communication skills.
• Ability to work effectively in a fast-paced manufacturing environment.

Responsibilities

• Execute manufacturing operations according to batch records, SOPs, and cGMP requirements with right first time execution.
• Set up manufacturing areas and operate automated and manual cell therapy processing, including cell expansion and filling.
• Ensure materials, equipment, documentation, cleanroom areas, and electronic systems are ready for scheduled activities.
• Author or update manufacturing batch records, work instructions, SOPs, logbooks, and production documentation.
• Support batch record reconciliation, documentation review, and timely closure of records.
• Participate in technology transfer, MSAT studies, and process development as assigned.
• Train and mentor Associate Specialists on GMP principles and procedures.
• Identify opportunities to improve safety, quality, schedule adherence, and production flow.

Skills

cGMP processes & quality systems

Aseptic technique

Cleanroom behavior

GMP documentation practices

GMP clinical manufacturing

Problem solving

Planning & organization

Written & verbal communication

Fast-paced environment adaptability

Cell therapy manufacturing experience

Design reviews & deviation handling

Batch records & MES familiarity

Data analysis (Excel)

Education

High School Diploma with related science/engineering experience

Tools

MES

Inventory systems

Quality management systems

Scheduling systems

Job description

AstraZeneca GmbH in Santa Monica, CA is hiring a Manufacturing Specialist, Cell Therapy to independently execute GMP manufacturing for TCR T, CAR T, and allogeneic cell therapy products. You will ensure quality, readiness, and accurate documentation while supporting technology transfer and continuous improvement.

The role requires strong aseptic technique, cGMP knowledge, and experience with batch records. You will mentor associates, uphold cleanroom standards, and collaborate across functions