Production Operator

Shift:

• Working Hours: M-F 8 hour shifts / subject to change to 4x10's shift on either Sun.-Wed. or Wed.-Sat.
• 3-month contract with potential for extension

Pay: $25.00/Hour


Overview:

• The role is responsible for supporting our dynamic Manufacturing team in the production of TCR-T, CAR-T, and allogeneic cell therapy investigational products
• Ensuring successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP
• Supporting manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations
• Using general application of principles, support activities to ensure GMP readiness for clinical manufacturing, including but not limited to equipment procurement, installation and qualification, facility qualification, and technology transfer.
• Setting up manufacturing areas and equipment, including complex automated cell processing equipment.
• Supporting Process Development (PD) and Manufacturing Sciences & Technology (MSAT) to align manufacturing plans with product development plans.

• Ensuring that all production operations are controlled and performed within cGMP regulatory guidelines
• Provide verbal and written updates to Manufacturing leadership.


Qualifications:

• 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 process and knowledge of CMC regulatory framework for biologics.
• Knowledge of industry practices, cell therapy manufacturing experience preferred
• Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations.

DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.