Bristol Myers Squibb Company

Senior Scientist - Analytical CMC Strategy

Devens, MA, United States
Sep 13, 2020
Required Education
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary:The Senior Scientist - Analytical CMC Strategy lead support serves as the point of a contact and contributor for BMS on the strategy & technical leadership for Biological Product assets in the Analytical Science & Technology organization (a member of the Biologics Operations Division). This role requires individual contributions and 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 testing laboratories around the world, managing the life cycle of products and specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

  • This position will be located at the Bristol-Myers Squibb site in Devens, MA. The Senior Scientist will collaborate across BMS sites with Analytical Science and Technology teams, Manufacturing Science and Technology, 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 product life cycle regulatory filings.
  • The Senior Scientist will be responsible for contributing and/or 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.
    • Functions as an individual contributor for analytical activities for late-stage and commercial programs in support of strategic decisions.
    • Operates within a matrix analytical team to support during all BLAs, ROW & PAS filings and reviews, 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


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 working across-functional strategic teams and collaboration with internal and external partners.
  • Strong knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings.
  • Demonstrated participant or lead 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 4, 10 or 13years 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

  • This position may require up to approximately 25% travel.

Supervisory Responsibilities
  • No direct reports (but leading in a matrix organization).

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.