Position SummaryThe 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 submissions outside of the US desired
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 preferred
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.
- They 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.
$170,000 (entry-level qualifications) to $187,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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 • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
