Manufacturing Specialist

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 positivelyimpactthe 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 aManufacturing Specialistto support our dynamic Manufacturing team in the production ofautologous cell therapyinvestigational products. This role is based inTarzana, CA. This rolewill report to the Associate Director of Manufacturingor Manufacturing Manager.

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

• Usinggeneral applicationof principles, support activities to ensure GMP readiness for clinical manufacturing, including equipment procurement, installation and qualification, facility qualification, and technology transfer.

• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.

• Assistin developing Standard Operating Procedures (SOPs) for manufacturing processes.

• Set up manufacturing areas and equipment, including complex automated cell processing equipment.

• Follow all cleaning and gowning procedures for the facility.

• Maintainappropriate inventoriesof material and supplies within the cleanroom areas to support manufacturing activities.

• Ensureall materials and equipment are identified and available in time for manufacturing activities.

• Support Process Development to align manufacturing plans with product development plans.

• Ensure that all production operations are controlled and performed within cGMP regulatory guidelines.

• Provide verbal and writtenescalationsto Manufacturing leads and manager, asappropriate.

• Perform other responsibilities and project-based assignments as needed to support manufacturing operations.

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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.

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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.

• Helpdeterminegoalsofassignment.

• Plan schedules and arrangesownactivities.

• Work is reviewed upon completionforadequacy in meeting goals.

• Be onsite 4 days a week to support a10 hourshift 

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The annual base pay (or hourly rate of compensation) for this position ranges from $81,992 to $122,989. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.