Associate Director, Regulatory CMC

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 Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority 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

• Provide expert opinion on CMC topics planned or performed
• Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards
• Assist with the development of global CMC regulatory strategies
• Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation
• Provide expert opinion on CMC topics planned or performed
• Assist with the design of CMC protocols
• Collaborate with other groups when needed to address CMC related matters
• Prepare responses to Health Authority comments and questions pertaining to CMC issues
• Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
• Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
• 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 10+ years of relevant progressive experience required; or
• Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or
• Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
• Experience in the management and preparation of the submission of CMC modules in eCTD format required
• Experience with organizing responses to Health Authority requests required
• Experience with regulatory submissions outside of the US preferred
• Experience managing staff preferred

Knowledge, Skills, & Abilities

• Strong knowledge of Health Authority CMC guidance documents and requirements
• Good leadership skills with the ability to direct and develop professional staff
• Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines
• Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred
• Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities
• Excellent organizatio