Senior Scientist - Analytical CMC Strategy
Location:
Devens , Massachusetts
Posted:
September 08, 2017
Reference:
1703428
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.

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.

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 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


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 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 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.
– 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.
Travel – This position may require approximately 25% travel.
Supervisory Responsibilities – No direct reports (but leading in a matrix organization).

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers


A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

Know someone who would be interested in this job? Share it with your network.