ImmunityBio
Senior Scientist, Regulatory CMC
Summit, NJ · Senior
Sponsorship not specifiedDetected 30 days ago
FDA RegulatoryCommunicationOrganizational SkillsRegulatory Affairs
About the role
- Provide input and recommendations on CMC topics planned or performed.
- 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.
Responsibilities
- 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.
- 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 Senior Scientist, Regulatory CMC will assist 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.
- Support the development of global CMC regulatory strategies.
- Support the design of CMC protocols.
- Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
- 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.
- 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.
Requirements
- Bachelor's Degree in life sciences or technical discipline with 6+ years' relevant progressive experience required
- Master's Degree in life sciences or technical discipline with 4+ years' relevant progressive experience required
- 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
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired
- Bachelor's Degree in life sciences or technical discipline with 6+ years' relevant progressive experience required; or
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.
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
Apply directly at ImmunityBio →Create a free account for alerts like thisView ImmunityBio immigration profile
This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.