Senior Scientist, Regulatory CMC

About the role

The Senior Scientist, Regulatory CMC and Principal Scientist positions at ImmunityBio, Inc. are responsible for developing and managing the chemistry, manufacturing, and control aspects of regulatory strategies for investigational and marketed products. These roles involve preparing and reviewing documents, interacting with cross-functional teams, and responding to Health Authority comments.

Responsibilities

• Prepare and review Module 2 (QOS) and Module 3 documents in accordance with 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.
• Design 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.

Requirements

• 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.

Qualifications

• 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.
• 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.

Skills

• 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.
• Strong organizational skills, written and oral communication skills, and attention to detail.

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) includes: 11 Holidays