Associate Director, Biologics CMC Documentation and Management (BCDM)

Bristol-Myers Squibb Pennington, NJ

About the Job

Description:

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Among our several NJ locations, our Hopewell and Bloomsbury sites are key components of the Biologics Network Strategy, with available Process Development and Analytical Development & Testing opportunities to support the innovating biologics under development. 

Principal Objective of the Position\: 
The leader of Biologics CMC Documentation and Management (BCDM) is an integral member of the Manufacturing Science and Technology (MS&T) organization and a key partner in ensuring that BMS brings drugs to patients with speed and quality. The BCDM leader is responsible for managing and preparing drug substance and analytical sections of the common technical document and manages the preparation of the entire dossier for all filings in the commercial life-cycle management space. The role requires effective collaboration across technical functions to deliver on accelerated timelines for submissions, standardization of submission processes, and alignment of technical documents with regulatory filings. It is expected that the leader understands best business practices for submissions and is able to work with consultants and vendors, as appropriate. The successful candidate will have an innovative and enterprise mindset, be well-organized, and have a passion for driving efficiencies and a culture of excellence in an organization. This position reports to the Executive Director and Head, Manufacturing Sciences and Technology, Drug Substance within the Operations area of Global Product Supply at Bristol-Myers Squibb.

Summary\:
The leader of Biologics CMC Documentation and Management (BCDM) is an integral member of the Manufacturing Science and Technology (MS&T) organization and a key partner in ensuring that BMS brings drugs to patients with speed and quality.  The BCDM leader is responsible for managing and preparing drug substance and analytical sections of the common technical document and manages the preparation of the entire dossier for all filings in the commercial life-cycle management space.  The role requires effective collaboration across technical functions to deliver on accelerated timelines for submissions, standardization of submission processes, and alignment of technical documents with regulatory filings.  It is expected that the leader understands best business practices for submissions and is able to work with consultants and vendors, as appropriate. 

The successful candidate will have an innovative and enterprise mindset, be well-organized, and have a passion for driving efficiencies and a culture of excellence in an organization. 

This position reports to the Executive Director and Head, Manufacturing Sciences and Technology, Drug Substance within the Operations area of Global Product Supply at Bristol-Myers Squibb.

Major Duties and Responsibilities\:
  • Manage the preparation of Drug Substance sections and Drug Product (DP) analytical sections of CMC regulatory filings for the development and marketing of products.
  • Manage the preparation of entire dossier for all post-approval filings in product life-cycle.
  • Develop authoring plans and strategic approaches to filings with Biologics Development and MS&T functions.
  • Promote standardization of submission processes within organization.
  • Ensure the use of appropriate document policies and standards to create “submission ready” documents.
  • Work with scientific consultants and vendors who contribute to submissions ensuring that appropriate information complies with FDA and appropriate health authority guidelines.
  • Develop, improve, and implement templates for CMC filings.
  • Coordinate with CMC matrix team leaders to ensure timely submissions.
  • Review and approve regulatory documents as head of BCDM (as directed by the authoring work practices for review of CMC submissions for Biologics).
  • Manage authoring of regional filings and amendments for approved products.
  • Work seamlessly across different functions for continuous improvement and increased efficiency in regulatory filing processes.
Qualification:
Knowledge and Skill\:
  • Master’s Degree in life-sciences, Ph.D. degree preferred
  • 5-7 years’ experience in preparation of regulatory documentation
  • 10+ years in the pharmaceutical industry with experience in biotech product development and manufacturing
  • Good understanding of biotech drug regulations essential (ICH and other governing documents US and global)
  • Excellent verbal and writing communication skills
  • Excellent collaboration skills with focus on timely delivery
  • Project management skills and experience required

Working Conditions\:

  • Principal assignment is in a modern office facility in Central NJ.  Staff is currently based in Hopewell, NJ and Syracuse, NY.
  • Occasional business-related travel is required, not generally exceeding two nights per month (5-10%). 

Decision Making\:

  • Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary.  
  • Works on well-defined assignments in collaboration with technical areas of the business.  
  • Identifies and evaluates opportunities for improvement in speed and efficiencies. 

Supervision Received\:

Works with minimal supervision on the accomplishment of agreed-upon goals and objectives. 

Supervisor Exercised\:
Incumbent has supervision over a staff of about 15 full-time and temporary employees.