Associate Director, CMC Portfolio Management

Responsibilities

• Manage activities to ensure functions have the right tools, reports, and AMP data for accurate resource estimates. Supports organization/communication of knowledge management materials (e.g. SharePoint/Team sites, etc.) for PPDST teams.
• 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.
• 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 R&D (Development Sciences, Regulatory, etc). Develop and provide advanced training courses, presentations, and guidance to foster best practices. Mentor junior staff on training, presentation development, and delivery.
• Bachelors degree required in a technical or scientific related discipline and 10+ years professional work experience in the pharmaceutical or biotech industry; or Masters degree with 8+ years of work experience; or Doctorate degree with 4+ 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.).
• 4+ 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 independ

Benefits

Additional Information

The Associate Director, 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. The candidate is expected to quickly excel at program management responsibilities and seek to establish themselves as a strategic leader of their teams and strong representative of the Development Sciences organization to senior leaders and cross-functional partners.

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Company Intel

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