Principal Scientist, Regulatory CMC at ImmunityBio in Summit, NJ

Job description

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. 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, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating 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). Key responsibilities will include contributing to 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 Contribute to 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 expert opinion on CMC topics planned or performed Contribute to 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 Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate 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 life sciences or technical discipline with 10+ years relevant progressive experience required; or Master’s Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 6+ 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 submission