Chemistry, Manufacturing and Control (CMC) methodology knowledge: Late Stage and Life Cycle Management
Drug Substance and Drug Product experience (Commercial process development and Commercial advancement)
Must be able to work on site and remote (remote-for limited time until site opens back up)
Must have Biology/Biochemistry/Biomedical/Chemistry background.
Must have experience with late stage, product development, and life cycle management, commercial process development, Process characterization, Tech transfer
2+ years of project management & 10+ years of experience within the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable
Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Projects may be strategic in nature. Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, business plan, design, testing, and implementation planning). Regularly interacts with management. Coordinates and directs the activities of project team members. May be responsible for cross-functional teams. Ensures all project requirements and/or objectives are documented. May obtain and manage external resources required for project completion.;
expertise in running medium to large scale projects ; excellent understanding of project management processes and procedures ; experience with project management and analyst methodologies and best practices ; strong analytical skills ; business process development best practices, change management ; strong MS Project, MS Word, MS PowerPoint and MS Excel skills, SharePoint ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross-program resources
This posting is for Contingent Worker, not an FTE"