Manager CMC Biologics
Bristol-Myers Squibb Pennington, NJ
About the Job
Responsible for the development and execution of regulatory CMC strategy for biologics, including biologics/device combination products.
- Represent CMC regulatory on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for BLAs, IND/CTAs, and briefing packages.
- Review and provide regulatory assessments on change controls.
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents and associated tracking systems.
- Manage relationships with diverse teams. Utilize electronic systems for dossier creation and tracking.
- Minimum of Bachelor's Degree with minimum of 4 years of related experience.
- Knowledge of CMC regulatory requirements for biologics during development and post-approval.
- Knowledge of pharmaceutical development, including biologic upstream and downstream processes, analytical methods, and biologic/device combination products.
- Demonstrated ability to develop/maintain strong working relationships with the GRS-CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
- Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
- Ability to interpret global regulations and guidance's.
- Strong oral and written skills.
- Proficient with electronic systems.