SR SCIENTIST 1(Job Number:1306190)
Description
The Senior Scientist/Engineer in Manufacturing Sciences & Technology (MS&T) will serve as the drug substance Process Champion or 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 Associate Director 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 management strategy and support, and the prioritization of each molecule technical agenda. The Process Champion role involves technical leadership and project coordination across all sites of drug substance manufacture for the designated product. The Process Champion represents drug substance manufacturing on the Integrated Development Team or Technical Product Team, and leads a cross-functional technical team that creates and governs the technical project portfolio for the designated product. 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 leads 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 franchise strategy. The position offers the opportunity to provide strong leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
Qualifications
Requires a PhD in Chemical/Biochemical Engineering or related disciplines with 4+ 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.
Job Function: Process Development
Primary Location: NA-US-MA-Devens
Organization
: GMS - Biologics Devens
Description
The Senior Scientist/Engineer in Manufacturing Sciences & Technology (MS&T) will serve as the drug substance Process Champion or 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 Associate Director 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 management strategy and support, and the prioritization of each molecule technical agenda. The Process Champion role involves technical leadership and project coordination across all sites of drug substance manufacture for the designated product. The Process Champion represents drug substance manufacturing on the Integrated Development Team or Technical Product Team, and leads a cross-functional technical team that creates and governs the technical project portfolio for the designated product. 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 leads 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 franchise strategy. The position offers the opportunity to provide strong leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
Qualifications
Requires a PhD in Chemical/Biochemical Engineering or related disciplines with 4+ 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.
Job Function: Process Development
Primary Location: NA-US-MA-Devens
Organization
: GMS - Biologics Devens
