Manufacturing Specialist

The Manufacturing Specialist supports and independently executes GMP manufacturing operations for TCR T, CAR T, and Allogeneic cell therapy investigational products. This role is based in Santa Monica, CA. with occasional support at the Tarzana, CA. sites as needed. The Manufacturing Specialist is responsible for successful execution of manufacturing processes, production readiness, material and equipment coordination, troubleshooting, documentation accuracy, and support of technology transfer. This role requires sound technical judgment, ownership of assigned activities, and the ability to work independently within established procedures and quality systems. You will serve as a technical contributor within the manufacturing team and supports the development of Associate Specialists through coaching, training, and process guidance. The primary purpose of this role is to execute manufacturing operations with a high level of quality, consistency, and independence. The Manufacturing Specialist supports clinical manufacturing, process implementation, technology transfer, GMP readiness, and continuous improvement. This role is expected to identify issues, resolve routine problems, escalate appropriately, and support right first-time execution across assigned manufacturing activities. Responsibilities Execute manufacturing operations according to batch records, SOPs, electronic work instructions, and cGMP requirements Set up manufacturing areas and operate automated and manual cell therapy processing equipment Ensure materials, equipment, documentation, and cleanroom areas are ready to support scheduled manufacturing activities Support equipment procurement, installation, qualification, facility readiness, and technology transfer activities as needed Follow and reinforce cleaning, gowning, aseptic technique, and contamination control expectations Maintain appropriate inventories of materials, supplies, and consumables within manufacturing areas Ensure required materials and equipment are identified, available, and ready in time for manufacturing execution Troubleshoot routine manufacturing issues and escalate risks or deviations as appropriate Support Process Development, MSAT, Quality, Supply Chain, and F&E to align manufacturing activities with process and business needs Support drafting, revision, review, and implementation of SOPs, batch records, and production documentation Participate in deviation investigations, CAPA implementation, change controls, and quality record support as needed Provide verbal and written updates to Manufacturing leadership Support shift handover communication and ensure critical production information is clearly transferred between teams Assist with training and mentoring Associate Specialists Identify opportunities to improve safety, quality, schedule adherence, and production flow Perform other responsibilities and project-based assignments as needed to support manufacturing operations Independent execution of assigned manufacturing operations in compliance with cGMP Right first-time performance across assigned process steps Accurate and complete documentation in real time Timely escalation of issues that may impact safety, quality, schedule, staffing, equipment, or materials Maintaining production readiness across materials, equipment, documentation, and cleanroom areas Supporting schedule adherence and cycle time expectations Contributing to deviation investigations with clear facts, process understanding, and timely input Supporting Associate Specialist development through training and coaching Required Qualifications At least 2+ years with BS/BA in relevant science or engineering discipline with 1-3 years of experience in cGMP or cell therapy manufacturing Understanding of cGMP processes and regulated manufacturing requirements Knowledge of aseptic technique, cleanroom behavior, and GMP documentation practices Experience supporting GMP clinical manufacturing, technology transfer, or process implementation Ability to develop solutions to routine and moderately complex problems using established procedures, precedent, and sound judgment Ability to plan and organize assigned work with limited supervision Ability to work effectively in a fast paced and changing manufacturing environment Preferred Qualifications Cell therapy manufacturing experience Experience with primary human cell culture, single use technologies, or automated cell processing equipment Experience supporting deviation investigations, CAPAs, change controls, SOP revisions, or batch record improvements Experience with paper and electronic batch records, manufacturing execution systems, inventory systems, or quality management systems Familiarity with CMC regulatory expectations for biologics or cell therapy products #CellTherapy The annual base pay for this position ranges from $68K to $102K. 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. Date Posted 09-Jul-2026 Closing Date 15-Jul-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.