Senior Program Manager, CMC Portfolio Management

Job Description

The Sr. Program Manager, CMC Portfolio Management leads with the development and maintenance of Chemistry, Manufacturing, and Controls (CMC) project plans for Product Presentation & Device Strategy Teams (PPDST) using standardized project management tools and processes. These CMC plans are used for decision making on drug development teams and across the R&D portfolio. Responsibilities include maintaining accurate PPDST rosters, generation of timeline swim lanes, and scenario planning interacting with Program Development Directors and key external stakeholders within R&D/Ops/Commercial.

Additional responsibilities include Early Biologics Excellence (EBE) pre-clinical timeline support and potential for involvement in program management support for due diligence assessment of external business development opportunities. The candidate is expected to quickly excel at program management responsibilities and establish themselves as a strategic leader of their teams and strong representative of the Development Sciences organization to senior leaders and cross‑functional partners.

• Independently provide advanced and extensive project management support to multiple complex (e.g. early-late stage, requiring a device, etc.) drug development and on‑market LCM projects, including creation and maintenance of CMC technical plans in Asset Management Platform (AMP), PPDST roster management, and timeline swimlanes for relevant program reviews.
• Lead the PPDST Team meetings, including setting agenda topics, capturing action items, and driving discussions with PPDST members. Drive PPDST team accountability to meet project deliverables. Develop multiple project planning scenarios in collaboration with PPDST team members; identify, monitor, and analyze business risks. Recognize when corrective action and planning are necessary and conduct root cause analyses (escalating recommendations to PPDST Team).
• Manage activities to ensure functions have the right tools, reports, and data for accurate resource estimates.
• Support organization/communication of knowledge management materials (e.g. SharePoint/Team sites, etc.) for PPDST teams.
• Independently identify opportunities for improvement of departmental work processes and manage large and small cross‑functional process improvement projects. Convert goals to tasks and coordinate activities to meet goals. Estimate and manage requirements to achieve defined objectives. Lead small teams through execution on defined objectives and keep management informed of progress and achieved project milestones.
• Apply advanced and extensive project management principles and techniques to the coordination and completion of assigned goals and tasks. Prioritize tasks with effective use of time.
• Support and advise peer Project Managers/PPDST Co‑Chairs on monthly project plan issues and timelines for maintenance and information reporting. Provide data entry for change requests. Define performance expectations and assess progress against plans, processes, and practices to determine effectiveness and areas for process improvement.
• Apply advanced project management tools for metrics collection and conduct advanced analysis of project data. Develop guidelines and checklists. Utilize and implement tools to identify novel solutions for metrics collection, data analysis and process improvement.
• Serve as local expert for business procedures and recommend solutions to the broader PM community. Develop and provide advanced training courses, presentations, and guidance to foster best practices. Mentor junior staff on training, presentation development, and delivery.
• Establish and maintain strong network within department and external stakeholders. Actively manage cross‑functional and departmental team behaviors, mediate internal team disputes, and facilitate establishment of high performing teams. May manage Sr. Specialists within the department. Interact with all levels of employees in support of project coordination. Effectively influence peer Program Managers regarding project initiatives and direction.

• Bachelor’s degree required in a technical or scientific related…