Senior Program Manager, CMC Portfolio Management

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 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 seek establish themselves as a strategic leader of their teams and strong representative of the Development Sciences organization to senior leaders and cross-functional partners.

Responsibilities:

•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.

•Leads the PPDST Team meetings, including setting agenda topics, capturing action items, and driving discussions with PPDST members. Drives PPDST team accountability to meet project deliverables. Develops multiple project planning scenarios in collaboration with PPDST team members; identifies, monitors, and analyzes business risks. Recognizes when corrective action and planning are necessary and conducts root cause analyses (escalating recommendations to PPDST Team).

•Manage activities to ensure functions have the right tools, reports, data for accurate resource estimates.

•Supports organization/communication of knowledge management materials (e.g. SharePoint/Team sites, etc.) for PPDST teams.

•Independently identifies opportunities for improvement of departmental work processes and manages large and small cross-functional process improvement projects. Converts goals to tasks and coordinates activities to meet goals. Estimates and manages 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. Defines performance expectations and assesses 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.

•Serves as local expert for business procedures and recommends 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 manages cross-functional and departmental team behaviors, mediates internal team disputes, and facilitates establishment of high performing teams. May manage Sr. Specialists within the department. Interacts with all levels of employees in support of project coordination. Effectively influences peer Program Managers regarding project initiatives and direction.

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•Bachelors degree required in a technical or scientific related discipline and 8+ years professional work experience in the pharmaceutical or biotech industry; or Masters degree with 6+ years of work experience; or Doctorate degree with 2+ years of work experience in same disciplines.

•Note: Higher education may compensate for years of experience; years of experience may compensate for education

•Accreditation in a project management or process improvement discipline highly preferred (e.g. Project Management Professional, LEAN Six Sigma, etc.).

•2+ years Project Management experience, including leadership of a cross-functional team required. Must be able to demonstrate knowledge of project management principles. Ability to work independently and represent sound strategies is required.

•Must have clear leadership skills t…