Manufacturing Specialist

AstraZeneca • Los Angeles, CA

1d • Onsite

About The Position

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 Manufacturing Specialist to support our dynamic Manufacturing team in the production of autologous cell therapy investigational products. This role is based in Tarzana, CA. This role will report to the Associate Director of Manufacturing or 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.

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 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.

Nice To Haves

• 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.
• Be onsite 4 days a week to support a 10 hour shift

Responsibilities

• Using general application of 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.
• Assist in 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.
• 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 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 escalations to Manufacturing leads and manager, as appropriate.
• Perform other responsibilities and project-based assignments as needed to support manufacturing operations.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees