Senior Scientist, Quality Control Analytical

Benefits

Additional Information

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 Senior Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations. Essential Functions Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology. Including: The polishing of analytical methods to implement GMP-friendly structure into the method. Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle. Complex troubleshooting of methods Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing. As required, provide training or mentorship to other QC or cross functional team members. Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture. Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities. In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate. Work with the QC team to improve the state of validation and drive analytical variability reduction. Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed. Lead continuous improvement activities to help improve the overall operations of the testing labs. Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence. Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals. Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience Master's degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of experience in the biotechnology industry required; or Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 3 years of experience in the biotechnology industry required. Extensive experience with assay development, qualification, validation, and transfer activities. Experience working in cGMP laboratory required Hands-on experience with HPLC and ELISA required Hands-on experience with biological assays (e.g. cell cultures) preferred Knowledge, Skills, & Abilities Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics With safety as the priority excellent laboratory techniques Proficiency in the use of multiple HPLC instrument platforms (e.g. Thermo, Agilent, etc.) Strong technical problem-solving ability both independently and as part of a team. Motivated to work independen