Specialist, Manufacturing

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Why ImmunityBio? ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. Work with a collaborative team with the ability to work across different areas of the company. Ability to join a growing company with professional development opportunities. Position Summary The Specialist, Manufacturing is responsible for leading and forwarding biological manufacturing. All functions and roles of the manufacturing process are required to be performed with adherence to cGMP and GDP to ensure successful, quality operations. The role participates in training and leading others as well as in fully supporting the scale up and transfer of new products. Essential Functions Performs manufacturing activities according to cGMP, including batch record execution, product and equipment changeover, troubleshooting manufacturing equipment, issue resolution under limited supervision Lead process operations in accordance to dynamic production timeline Lead safety protocols and cGMP compliance in manufacturing areas. Investigate and resolve problems, identifying root causes, and proposing process improvements through clear communication Perform aseptic processing operations. Operate manufacturing equipment and their operating systems. Operate and may maintain in-process production schedules. Develop, author and revise operational and equipment MBRs and SOPs Maintain gowning qualification status and as needed participates in annual media simulation fills as required. Review manufacturing documentation following good documentation practices Perform process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements. Collaborate within department, cross-functionally and with supporting areas to meet objectives, cross-train and support other areas. Contribute to and help develop process improvement initiatives. Ensure that equipment and materials are ready and available for production runs. Maintain and sustain personal training profile requirements. Facilitates keeping training profiles up to date. Support investigations, CAPA and change control procedures. Responsible for performing On-The-Job training of manufacturing operators in areas of expertise and supporting training for trainees. Prepare daily manufacturing schedules. Leads manufacturing operational teams to meet on-time schedule requirements. Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor’s degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field required. 4+ years of relevant industry or research experience required. 2+ years’ Bio-Manufacturing experience required. GMP experience required. Knowledge, Skills, & Abilities Strong skills in preparing reports with Microsoft Word, preparing, and updating Excel spreadsheets and presentations. Able to effectively author and revise Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs). Ability to problem solve using continuous improvement tools to identify problems, determine root causes, subsequent solutions and bring about the solution and improvement. Ability to present cross functionally to convey information and findings clearly, professionally, efficiently, and effectively. Attention to detail, cleanliness, physical and mental flexibility. Good perce