Associate, Quality Control – Cell Culture

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 Associate, Quality Control - Cell Culture is responsible for ensuring the timely execution of Quality Control Analytical assays in support of product release across all of Immunity Bio’s oncology and vaccine product platforms. This position requires expertise with cell culture and cell based assays. This role will interact cross-functionally with members of the Manufacturing, Quality Assurance, Analytical Development, and Process Sciences teams. Essential Functions Ensure and support a safe working environment for work areas. Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements. Participate in method qualification, validation and transfer activities. Support instrument installation and operational qualification activities (IOQ). Ensure a compliant work space by adhering to and enforcing GxP requirements. Support and/or lead out of specification and out of trend investigations and implement corrective actions as needed to prevent reoccurrence. Approve testing performed by other team members to ensure timely release of test data. Ensuring the integrity of all data generated. Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance. Ensure timely escalation of all assay related challenges/issues and assist in developing countermeasures to improve performance. Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence. Participate and/or lead continuous improvement activities to help improve the overall operations of the testing labs. Maintain analytical laboratory in a state of control, compliance, and inspection readiness. Interface with all auditors (internal and external) to ensure positive audit outcomes. Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals. Adhere to and contribute to creating Standard Operating Procedures (SOPs) and process improvements. 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 a life sciences discipline with 1+ years of relevant experience required Experience and knowledge of analytical cell-based assays preferred Experience with the technical transfer and qualification/validation of analytical assays preferred Knowledge, Skills, & Abilities Fundamental knowledge of cell and molecular biology, and immunology. Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings. Strong problem-solving skills with demonstrated attention to detail. A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines. Working Environment / Physical Environment This position works on site in Torrey Pines, CA. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. Will require occasional w