Scientist II IV/ Senior Scientist, Solid State & API Engineering The qualified candidate will be hired at the appropriate level commensurate with education and experience. This position will support the development of novel biologically active compounds within the BI pipelines. A knowledge of the drug development process and application of solid state chemistry, process c

Project Management Experience with various product management methodologies and frameworks, including Agile, Scrum, Waterfall, Kanban, and Hybrid. Define and document project scope, objectives, and desired outcomes. Prepare an estimated timeline based on the project scope. Set and manage stakeholder expectations, both internally and externally. Team Management Managing cr

Trial Preparation Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5 8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. Conduct on site visits to assess CRA performance, including co monitoring/supervisory visits, as requested, including oversight of CR

Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations. Accountable for Patient Narrative pr

As a scientist, you will help aid in LC/MS based analytical techniques, computational programing, and will be responsible for Mass Spectrometry (MS) quality control (QC) support for CRO produced proteins/ antibodies. You will help develop automation platforms and writing mass spectrometry related computer programs to support the Biotherapeutics Discovery team. You will he