Principal Scientist, Regulatory CMC

ImmunityBio, Inc. is a commercial-stage biotechnology company developing cell and immunotherapy products. 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.

Requirements

• 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

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO)