Bristol-Myers Squibb Company

Associate Director Analytical Product and Strategic Lead

Location
Devens, MA, US
Posted
Sep 29, 2018
Ref
R1508604
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Associate Director - Product and Strategy Analytical Lead serves as the point of a contact for BMS on the strategy & technical leadership for Biological Product assets for the Analytical Science & Technology organization within the biologics operations division. This role requires leadership of a matrix team of Analytical Scientists supporting commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

Duties/Responsibilities:

This position will be located at the Bristol-Myers Squibb site in Devens, MA. The Associate Director will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the analytical commercial strategies for late phase and commercial products.

The Associate Director will be responsible for leading a team of both direct and matrix reports responsible for delivery of drug substance and drug product analytical control strategies including methods, specifications, and comparability studies. In addition the associate director will contribute directly and through the team to prepare global licensure applications, define strategy for follow-up measures, and prior approval submissions as well as author/review associated regulatory filings.

Through strong leadership, the Associate Director will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and partners at external testing labs.

Additional responsibilities include:

- Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.

- Accountability for strategy and execution of analytical activities required to advance late-stage programs and manage the lifecycle of commercial programs.

-Leads a team responsible for delivery of analytical CMC strategy; provide

- Supervises colleagues responsible for various aspects of analytical CMC strategy definition and/or execution. Ensures appropriate impact and output of all colleagues through effective performance management and career development

-Leads effective matrix analytical support during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.

- Co-leads the effort to implement effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.

- Coordinates optimization and improvement of analytical program support.

-Serves as project expert during inspections

-Contributes to strategy and operations across the Analytical Sciences and Technology organization

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc:

- Demonstrates a broad expertise and knowledge in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product. Experience in product characterization and strategies to establish process and product knowledge.

- Strong communication and leadership skills in a highly interactive environment.

- Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners.

- Comprehensive knowledge of biologics CMC regulations and working knowledge of cGMP requirements

- Experience authoring/reviewing regulatory submissions

- Demonstrated leadership capability (via direct supervision or leadership of matrix teams).

Education/Experience/ Licenses/Certifications:

- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 10, 13 or 15 years of industrial experiences in relevant fields, respectively.

Physical Demands

- This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including ...
  • Sitting
  • Walking-Level Surfaces

Work Environment

- This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including ...
  • Inside Work
  • Working Alone
  • Working with/around others
  • Chemicals

Travel

- This position may require approximately 25% travel.

.

Supervisory Responsibilities

- Yes.