Senior Scientist I
About the Job
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.
Senior Scientist I, Global DS MS&T – Materials Science Description\: The Senior Scientist I in the Global Drug Substance Materials Science group will support the development of raw material control strategies for the commercial manufacturing of biopharmaceuticals. The scientist will serve as the lead for raw material characterization and robustness for internal and 3rd party manufacturing sites. The successful candidate will collaborate closely within the Manufacturing Sciences and Technology organization as well as with representatives from Process Development, Global Procurement, Supply Chain, Manufacturing, Manufacturing Technology, Quality Assurance, Analytical Sciences and Global Regulatory Sciences on cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives. The position involves such material management activities as\: raw material trending and characterization in relation to process robustness, material specification development support, technical material risk assessments, alternate supplier qualifications, and supplier change management.
- Using innovative techniques, determines critical material attributes related to process performance
- Partners with Global Procurement and material suppliers to implement material robustness solutions.
- Provides technical expertise and authorship for\: manufacturing investigations, new material implementations, material change controls, technical material risk assessments, and the preparation of regulatory filings in support of commercial manufacturing operations.
- Demonstrates mastery of SOPs and cGMPs and additional Quality Compliance requirements
- Leads cross functional teams (Supply Chain, Quality Control and Assurance, Manufacturing, Global Procurement, etc) for material change management, and process technical transfers
- Provides material subject matter expertise for health authority inspections and interactions with regulatory agencies.
- Leads raw material scientists located at internal sites.
- An understanding of raw material characterization and variability in biopharmaceutical applications
- Knowledge of biologics manufacturing processes preferred.
- Ability to manage scientists that may be located at different sites.
- Ph.D. with a minimum of 5 years relevant experience or M.S. with equivalent experience
- Awareness of cGMP compliance and regulatory agency requirements.
- Proven project management skills, including leading cross functional teams and balancing project assignments.
- Demonstrated problem solving ability.
- Strong oral communication and technical writing skills are essential.
- The position is based at the Bristol-Myers Squibb Devens Facility. Travel is required.
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.