Chemistry, Manufacturing & Controls (CMC) Senior Project Manager

United States, California, South San Francisco

Location: South San Francisco


PTD Project and Portfolio Management (PTDMM) Department

 

PTDMM supports the Technical Development Team systems and governance bodies (LSTDC, ESTDC, etc.) for CMC project and portfolio decision-making and delivery of the CMC pipeline by providing project management expertise and portfolio information and insight.

 

Project Manager / Senior Project Manager Job Description 


We are seeking a Project Manager/ Senior Project Manager who will manage CMC project teams to successful and timely decision points from Late Stage Research (prior to FIH) through approval (NDA, BLA, MAA). The Project Manager/Senior Project Manager will
partner with a CMC Technical Development Leader (TDL) to help teams successfully define their CMC project strategy and deliver on project objectives. As a member of the PTDM-M department, they will also have the opportunity to project manage cross-functional initiatives across the PTD group. This position requires excellent communication, collaboration, negotiating, influencing and strategic thinking.

 

Additional responsibilities include but are not limited to the following:

 

·      Serve as strategic and technical partner to CMC Technical Development Leader (TDL), helping to drive CMC strategy in alignment with development team goals and technical functions on 3 – 5 CMC teams

·      Ensure teams achieve and maintain a high-level of sustainable performance, by directly contributing or leading appropriate team management best practices

·      Facilitate and manage project teams and monitoring of critical path and team activities, including documenting meetings, decisions, risks and actions; cross-functional communication; and tracking of technical deliverables

·      Establish and maintain CMC aspects of functionally integrated project schedules to enable accurate project, financial and portfolio analyses, and ensure accurate inputs are provided into business planning processes

·      Apply drug development knowledge to different technical platforms such as large molecule, device, small molecule, version change and/or antibody drug conjugate in either the gRED, late stage or post market phases, in order to drive CMC teams to informed decision making, and optimal alignment of all technical deliverables within the Project Team System

·      Proactively communicate issues and concerns providing transparency with key customers and stakeholders in a global setting; act as a primary CMC contact for multiple functional areas across project teams

·      Provide timely presentations to Senior Management meetings and information for reporting such as the annual budgeting process, appropriate governance committees, and monthly reporting

·      Drive business and corporate processes for CMC team, including risk assessment, governance and goal-setting

·      Oversee CMC team budget, including resources and costs, collaborating with team members, cross-functional department resource planners and development team Project Managers

o   Identify, recommend and implement opportunities for streamlining team and business processes, serving as advocate and role model for integrating change into organization

o   As a member of the Global PTDM organization participate in staff meetings, global TDL/PM forums and department initiatives