| 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.
PRINCIPAL OBJECTIVE OF THE POSITION:
The leader of Manufacturing Sciences & Technology, Drug Substance in Devens is responsible for scientific and technical oversight of biologics manufacturing processes from full-scale process validation through commercialization and life-cycle management at Devens manufacturing facility. Support to the external network of biologics drug substance manufacturers will be required as well, which includes continued process verification, and development/characterization/validation of next generation processes as applicable. This position reports to the Executive Director and Head, Manufacturing Sciences and Technology, Drug Substance within the Biologics Development and Operations department of Bristol-Myers Squibb's Global Manufacturing and Supply Division. The main responsibility of the Director, Manufacturing Sciences and Technology, Drug Substance in Devens is to provide robust and timely technical support to biological products manufactured at the Devens site, in close collaboration with the leaders in Manufacturing and Quality at the Devens site. The Director will be part of the Devens Site Management Team.
MAJOR DUTIES AND RESPONSIBILITIES:
•Oversee Upstream and Downstream MS&T laboratories to support biological drug substance processes at Devens, Massachusetts and contract manufacturing organizations. •Oversee Manufacturing Technology functions supporting commercial manufacturing at Devens site. •In collaboration with Biologics Process Development, responsible for large-scale technical-transfer activities for late-stage clinical and commercial manufacturing processes, including establishment and support of process control strategies, specification windows, and comparability packages that lead to successful validation and commercialization. •Accountable for process validation from writing protocols through execution for biologics drug substance manufactured in Devens. •Accountable for CMC authoring, reviewing, and health authority responses for?biologics drug substance?manufacturing in Devens and at CMOs. •Identify and implement commercial-process and life-cycle improvements, including next-generation process development and characterization. •Assure manufacturing operations in Devens, Massachusetts?are aligned with the registered processes and adhere to current Continued Process Validation and other lifecycle management regulations. •Provide support for facility, process, and raw material technical investigations and change controls. •Define relevant operational/technical standards and practices for Devens. •Collaborate with global functions to identify raw material and consumable specifications and standards for Devens and the global manufacturing network.
The Director, MS&T is in direct contact with the plant's General Manager and other senior leaders within the site, including heads of Quality, Technical Services, EH&S, Supply Chain, and all Manufacturing team members.? Occasional interactions occur with external industry and regulatory representatives.
Principal assignment is in a modern office facility; however this role involves frequent visits to the Large Scale Cell Culture (LSCC) and the Devens Clinical Manufacturing Facility (Single Use Facility) buildings which may require adherence to various Personal Protective Equipment (PPE) standards.
Occasional business-related travel is required, not generally exceeding?four nights per month.
Exercise sound judgment in making decisions and recommendations within generally defined practices and policies, and notify senior management when necessary.? Works on abstract problems across functional areas of the business.? Identifies and evaluates fundamental issues for major functional areas through assessment of tangible variables.? Erroneous decisions will have a serious impact on the overall success of division operations.
Works with minimal supervision on the accomplishment of agreed-upon goals and objectives.
Incumbent has supervision over a staff of about?60 full-time and temporary employees.
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.