Bristol-Myers Squibb Company

Analytical CMC Scientist

Location
Devens, MA, US
Posted
Aug 25, 2018
Ref
R1507733
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary:

A Scientist in the Analytical CMC Strategy group plays a supporting role for biopharmaceutical products' lifecycle activities. This position focuses on support for commercialized and late-stage 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. The scientist may serve as the point of a contact for Analytical Science and Technology (AST) group, which resides in the Global Quality Organization. This role requires operating and leading in a matrix team environment of analytical scientists.

Duties/Responsibilities:

This position will be located at the Bristol-Myers Squibb site in Devens, MA. The scientist will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the pre- and commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings.

The scientist will operate in a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions. Through strong leadership, the 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. The scientist is responsible for data gathering, interpretation and presentation to support decision making and product analytical strategies.

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, as necessary.

- Manage and coordinate analytical activities for late-stage and commercial programs.

- Effectively supports team matrix for analytical topics during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.

- Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.

-Serves as subject matter expert for project for activities, including technical evaluations of methods and data.

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc:

- Comprehensive knowledge and experience in analytical methodologies used for the development and commercialization of biologics. Demonstrates a broad expertise and experiences 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.

- Experience in cross-functional strategic teams and collaboration with internal and external partners.

- Working knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings.

Education/Experience/ Licenses/Certifications:

- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 2, 6 or 8 years of industrial experience 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 requires approximately 25% travel.