Bristol-Myers Squibb Company

Senior Scientist

Location
Devens, MA, US
Posted
Sep 07, 2018
Ref
R1508606
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Senior Scientist - 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 Senior Scientist will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings.

The Senior Scientist will be responsible for leading a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, and prior approval submissions.

Through strong leadership, the Senior Scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside 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.

- Supervise the management of analytical activities for late-stage and commercial programs.

- 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

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 stablish 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 cGMP requirements, as well as, experience in supporting regulatory filings.

- Demonstrated leader of matrix teams of scientists and/or project management professionals.

Education/Experience/ Licenses/Certifications:

- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 5, 8 or 10 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.

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Supervisory Responsibilities

- No direct reports (but leading in a matrix organization