Production Operator

AstraZeneca's Oncology R&D division follows the science to explore and innovate, working towards treating, preventing, modifying, and curing some of the world's most complex diseases. This role supports the dynamic Manufacturing team in the production of TCR-T, CAR-T, and allogeneic cell therapy investigational products in Tarzana, CA, with occasional travel to Santa Monica, CA.

About the role

This 12-month contract position ensures successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP. The role supports manufacturing operational readiness and the successful technology transfer of pipeline products. The assignment may be extended based on project needs, performance, and budget availability. Compensation and employment terms will be managed through an approved staffing partner; this role is not eligible for company-sponsored benefits unless provided by the staffing agency.

Responsibilities

• Support activities to ensure GMP readiness for clinical manufacturing, including equipment procurement, installation and qualification, facility qualification, and technology transfer.
• Perform operational tasks within a cleanroom environment in compliance with safety policies, quality systems, and cGMP requirements.
• Assist in developing Standard Operating Procedures (SOPs) and other documents for manufacturing processes.
• Set up manufacturing areas and equipment, including complex automated cell processing equipment.
• Follow all cleaning and gowning procedures for the facility.
• Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
• Ensure all materials and equipment are identified and available in time for manufacturing activities.
• Support Process Development (PD) and Manufacturing Sciences & Technology (MSAT) to align manufacturing plans with product development plans.
• Ensure all production operations are controlled and performed within cGMP regulatory guidelines.
• Provide verbal and written updates to Manufacturing leadership.
• Perform other project-based assignments as needed to support manufacturing operations.
• Experience with CAR-T immunotherapy production as operator/verifier/runner and deviation support.
• Operate cell therapy equipment such as NC-200 Nucleocounter Automated Cell Counter, Dynasellect, Cue, Welder, Sealer, Microscope, Sefia, Finia, Sepax, and ISO 5 aseptic operations.

Requirements

• Minimum of five (5) years of experience with a High School Diploma or a BS/BA in a relevant science or engineering discipline.
• Understanding of cGMP processes and knowledge of CMC regulatory framework for biologics.
• Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing, including tech transfer and clinical/commercial manufacturing operations.
• Develop solutions to complex problems independently using established precedents, policies, or original thinking.
• Help determine goals of assignments and plan schedules and activities.
• Cell therapy manufacturing experience preferred.

Pay

$25.20 per hour.

Schedule

Monday–Friday, 7:00 AM–3:30 PM, transitioning to Sunday–Wednesday, 7:00 AM–5:30 PM. In-person work averages a minimum of three days per week from the office, balancing on-site collaboration with individual flexibility.