ImmunityBio
Principal Scientist, Regulatory CMC
Summit, NJ · Principal
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About the role
- Contribute to the development of global CMC regulatory strategies
- Provide expert opinion on CMC topics planned or performed
- Interact with other groups when needed to address CMC related matters
Responsibilities
- Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards
- Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation
- Contribute to the design of CMC protocols
- 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.
Requirements
- Bachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required
- Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required
- 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 regulatory submissions outside of the US desired
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- 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
Nice to have
- Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred
Skills
- Knowledge, Skills, & Abilities
- Strong organizational skills, written and oral communication skills, and attention to detail
Compensation
- The annual base pay range for this position is below.
Benefits
- Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues
- Familiarity with organizing responses to Health Authority requests required
- Knowledge of Health Authority procedures and guidance regarding document management and electronic submission
Company info
- At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.