Sr Scientist/Engineer I - Matrix Team Lead - Drug Substance Process Champion
About the Job
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
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 Drug Substance Process Champion in Manufacturing Sciences & Technology (MS&T) will serve as the cross-functional technical lead for drug substance manufacturing for one or more late-stage clinical or commercial biological products. The Drug Substance Process Champion in Manufacturing Sciences & Technology (MS&T) will serve as the cross-functional technical lead for drug substance manufacturing for one or more late-stage clinical or commercial biological products. The position is located in Devens, MA and reports to the Principal Engineer of Process Lifecycle Management in MS&T. The Process Lifecycle Management function for biologics serves as the focal point for process technical support from launch through the commercial life of biological processes. The group is responsible for leading process validation of new pipeline products and, upon product licensure, the life-cycle technical strategy and support, and the prioritization of each molecule’s technical agenda.
- The Process Champion role is highly cross-functional and challenging, involving technical leadership across all sites of drug substance manufacture for the designated product.
- The Process Champion helps set strategy for the product franchise by representing drug substance on product strategy teams, and leads a cross-functional technical team that creates and governs the technical project portfolio for the designated product.
- The Process Champion interacts regularly with site and corporate leadership in assessing resources required, communicating progress and risks, and presenting timelines and strategies for endorsement.
- The Process Champion represents the drug substance manufacturing process in regulatory interactions such as inspections and other meetings.
- The Process Champion serves as the primary owner of the drug substance process, and leads or participates in large-scale process validation, regulatory filings, regulatory inspections and responses, technical transfers, troubleshooting teams, change control efforts, process monitoring, continuous improvement, and other technical initiatives.
- The Process Champion collaborates in efforts involving the site-based MS&T teams to troubleshoot manufacturing issues and develop process improvements using scale-down models of the drug substance manufacturing process.
- The Process Champion collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy.
- Requires a PhD or MSc in Chemical/Biochemical Engineering or related disciplines with 4+/8+ years of experience in biologics processing.
- Experience with cGMP regulations, regulatory requirements and CMC authoring for biologics process validation and manufacturing are necessary.
- Experience in working in / leading cross-functional teams is essential and knowledge of mammalian-based biologics manufacturing processes is preferred.
- Demonstrated problem solving ability, interpersonal, and oral and written communication skills are essential along with strong leadership skills.
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.