Manufacturing Specialist

Manufacturing Specialist Location: Santa Monica CA and Tarzana, CA Shift: Wed-Sat 0700 to 1730 (1st 3 months will be Mon-Fri 0800-1630), with flexibility to work a varied schedule. Position Summary AstraZeneca is seeking a highly motivated individual for the role of Manufacturing Specialist, to join our Manufacturing team, to work in an exciting new area of cell therapy at AstraZeneca. This position is based out of Santa Monica, CA as well as occasional travel to Tarzana, CA. This role reports directly to the Associate Director, Manufacturing. The Manufacturing Specialist role will be responsible for ensuring successful manufacture and release of cell therapy products following all processes and procedures related to operations in full compliance with cGMP. This role will be driving and supporting the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations. Responsibilities (include but not limited to): Using general application of concepts and principles supports activities to enable 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 the development of Standard Operating Procedures (SOPs) for manufacturing processes. Assist in setting 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 and MSAT to align manufacturing plans with overall product development plans. Ensure that all production operations are controlled and executed within cGMP regulatory guidelines. Provide timely verbal and written updates to Manufacturing leadership. Support all new product/process introductions on site Interact with vendors and outside resources Complete assigned projects Be the shift lead if required, providing instruction to the team Troubleshoot and resolve operational problems during processing Represent Manufacturing in cross-functional initiatives and meetings Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate Manage multiple projects independently Plan and implement complex changes Perform Environmental monitoring as required Technical expert for entire area(s) Interact independently with regulatory agencies Develop and provide training on complex manufacturing processes Perform Manufacturing review and approval of critical documents Develop process validation protocols Maintain good housekeeping and clean and sanitize classified areas as required Analyze complex problems and determine and implement solutions Other duties and projects assigned to meet business needs. Essential Requirements: 2+ Years with BS/BA in relevant science or engineering discipline with 1-3 years of experience in cGMP or cell therapy manufacturing. 1+ Years with MS/MA or Eng Degree with a minimum of 5 years experience within a pharmaceutical or biotech industry with increasing levels of responsibility and operational excellence or Lean manufacturing principles preferred. Clear understanding of cGMP process and knowledge of CMC regulatory framework for biologics. Experience of aseptic techniques for primary human cell cultures and GMP manufacturing. Direct experience supporting tech transfer and GMP clinical/commercial manufacturing operations. Experience with single use technologies and tools for cell culture. Organization skills for day-to-day activities and excellent communication and interpersonal skills. A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems. Ability to drive safety, quality, functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness. Ability to make timely decisions and knowing when to escalate and when to delegate Preferred Additional Qualifications: Proficient understanding and application of principles, concepts, practices, and standards. Wide range knowledge of industry practices, cell therapy manufacturing experience highly desirable. Able to work within and adapt to complex electronic systems such as SAP and EQV Develop solutions to complex problems independently. Refer as necessary to established precedents and policies or use original thinking. Work is performed under minimal direction. Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. Provides direction to subordinates based on general policies and management guidance. 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 incentivesan 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 11-Mar-2026 Closing Date 24-Mar-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 worlds most serious diseases. But we are more than one of the worlds leading pharmaceutical companies. At AstraZeneca, were 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. Were curious about science and the advancement of knowledge. We find creative ways to approach new challenges. Were 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, youll do work that has the potential to change your life and improve countless others. And, together with your team, youll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.