Location: Tarzana, Ca
Duration: 3 months w/possibility of extension
Working Hours: M-F 8 Hours; subject to change to 4x10's shift on either Sun.-Wed. or Wed.-Sat.
Pay rate: $25.20 per hour
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary:
We are seeking a Contract Manufacturing Specialist to support our dynamic Manufacturing team in the production of TCR-T, CAR-T, and allogeneic cell therapy investigational products. This contract role is based in Tarzana, CA, with occasional travel to Santa Monica, CA as needed. The contractor will report to the Associate Director of Manufacturing, NGF70.
The Specialist, Manufacturing role will ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP. This role also supports manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.
Responsibilities:
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.
Perform operational tasks within a cleanroom environment in a manner consistent 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 that all production operations are controlled and performed within cGMP regulatory guidelines.
Provide verbal and written updates to Manufacturing leadership.
Perform other responsibilities and project-based assignments as needed to support manufacturing operations.
Experience and Education:
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 aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations.
Additional Requirements:
Knowledge of industry practices, cell therapy manufacturing experience preferred.
Develop solutions to complex problems independently.
Refer to established precedents and policies or use original thinking.
Help determine goals of assignment.
Plan schedules and arranges own activities.
Work is reviewed upon completion for adequacy in meeting goals.
-CAR-T immunotherapy production operator/verifier/runner
-Deviation support
-Experience with operating cell therapy equipment such as NC-200 Nucleocounter Automated Cell Counter, Dynasellect, Cue, Welder, Sealer, Microscope, Sefia, Finia, Sepax, and ISO 5 aseptic operations
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