Senior Scientist, Regulatory CMC

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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, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards. Support the development of global CMC regulatory strategies. Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation. Provide input and recommendations on CMC topics planned or performed. Support the design of CMC protocols. Interact with other groups when needed to address CMC related matters. Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues. May train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate. Perform 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 life sciences or technical discipline with 6+ years' relevant progressive experience required; or Master's Degree in life sciences or technical discipline with 4+ years' relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 2+ years' relevant progressive experience required. Experience in the preparation of the submission of CMC modules in eCTD format required Familiarity with organizing responses to Health Authority requests required Familiarity with regulatory submissions outside of the US a bonus Knowledge, Skills, & Abilities Knowledge of Health Authority procedures and guidance regarding document management and electronic submission Knowledge of Health Authority CMC guidance documents and requirements Proficient in Electronic Document Management Systems Ability to work with firm deadlines and adapt quickly to changing requirements and priorities Strong organizational skills, written and oral communication skills, and attention to detail Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired Working Environment / Physical Environment This position works on site in Summit, NJ. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This position may need to sit for long periods of time and use various computer programs. This desk-based role involves the close study of scientific and regulatory documents. This position will work closely with scientific colleagues throughout the day, often on a project team basis. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $140,000 (entry-level qualifications) to $154,000 (high