Manager CMC Biologics

Bristol-Myers Squibb Pennington, NJ

About the Job

Description:

Responsible for the development and execution of regulatory CMC strategy for biologics, including biologics/device combination products.  


Responsibilities Include\:

  • 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.

 

Qualification:

  • 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.