Director, Commercial QCA

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 Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program and all other QCA programs that are advancing to the commercial stage.. Essential Functions Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability). Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies. Ownership and oversight of all assay trending programs Design and implement methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability. Design and implement strategies to transfer methods into QCA groups. Ensure QCA decisions align with Quality System, GMP and regulatory requirements. Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation. Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance. Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems. Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor’s degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level required; or Master’s degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level required; or Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level required Extensive experience with assay qualification, validation, and transfer activities required Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome required Experience with a start-up pharmaceutical company preferred Knowledge, Skills, & Abilities Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques. Understanding of cell therapy processes is desirable Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities