Principal Scientist, Analytical Development - Process Science

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 Principal Scientist, Analytical Development - Process Sciences will collaborate with internal and external partners to develop, qualify and implement methods across ImmunityBio’s platforms and advance our pipeline. This role will serve as a key technical leader and mentor within the Process Sciences department, driving innovation in method development and characterization from early-stage development through late-stage commercialization.  The Principal Scientist will support TechOps management and Regulatory Affairs personnel with regulatory filings and provide guidance and consultation to members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams while overseeing timely execution of samples in support of process development activities.  Essential Functions Lead the design, development and qualification of robust analytical methods for therapeutic proteins, viral vectors and whole cell products.  This includes chromatography, electrophoresis, and cell-based or binding bioassays Lead method transfer activities ensuring seamless transfer of assays to and from Quality Control or external Contract Development and Manufacturing Organizations Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance Serve as principal technical subject matter expert (SME).  Provide mentorship, training and strategic guidance to less junior team members, fostering a collaborative and high-performing laboratory culture Author and review high-quality technical reports, protocols, validation plans, and CMC sections for regulatory submissions (IND/BLA).  Ensure all activities align with ICH guidelines and USP/EP compendial requirements Collaborate with and monitor contract testing laboratories and consultants, ensuring compliance with company procedures Perform and guide others in a variety of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF to assess product quality and characterize products Perform formulation and stability support by performing force degradation studies Advise and support efforts for method troubleshooting remediation, change, and optimization efforts in conjunction with Quality Control Lead support activities for the Process Development teams to characterize process improvements and develop new products Oversee the maintenance, calibration and operation analytical equipment and instruments Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience Ph.D. in Chemistry, Biochemistry, Molecular Biology or related scientific field with 6+ years of relevant experience in the biopharmaceutical industry required; or MSc in Chemistry, Biochemistry, Molecular Biology or related scientific field with 9+ years of relevant experience in the biopharmaceutical industry required; or Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific field with 12+ years of relevant experience in the biopharmaceutical industry required. Extensive experience in method development, method validation, and method transfer is required. Previous supervisory experience strongly preferred Knowledge, Skills, & Abilities Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF Working knowledge of biological assays including ELISA, cell-based potency assays, and flow cytometry Familiarity with formulation development is required, hands-on experience with formulation development is highly desired Demonstrated ability to translate complex analytical data into actionable insights for cross-functional process development, manufacturing, quality assurance and quality control teams Self-motivated and willing to accept temporary responsibilities outside of initial job description Excellent interpersonal, verbal and written communication skills Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities Strong project management skills.  Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams Strong statistical analysis skills Strong technical writing skills with experience reviewing and approving: SOPs, analytical test methods, qualification and validation protocols/reports, summary reports, and CMC sections of FDA and EMA filings Working Environment / Physical Environment This position works on s