Senior Program Manager, CMC Portfolio Management

About the role

The Senior Program Manager, CMC Portfolio Management leads 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

• 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.

Requirements

• Bachelor’s degree required in a technical or scientific related discipline and 8+ years professional work experience in the pharmaceutical or biotech industry; or Master’s 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 that minimally include: strong written and effective interpersonal communication; capability to clearly present, influence, and logically justify proposals; sound judgment; negotiation and conflict management; effective communication across cultures and disciplines; relationship building and fostering teamwork; and training experience.
• Job requires knowledge of the drug development process.
• Cross-functional and global project team leadership experience preferred.
• Proficient in the tools and techniques of Project Management and/or Business Excellence (e.g., MS Office software, MS Project, Qlikview, Spotfire, etc.).
• CMC experience preferred.

Qualifications

• Bachelor’s degree required in a technical or scientific related discipline and 8+ years professional work experience in the pharmaceutical or biotech industry; or Master’s 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 that minimally include: strong written and effective interpersonal communication; capability to clearly present, influence, and logically justify proposals; sound judgment; negotiation and conflict management; effective communication across cultures and disciplines; relationship building and fostering teamwork; and training experience.
• Job requires knowledge of the drug development process.
• Cross-functional and global project team leadership experience preferred.
• Proficient in the tools and techniques of Project Management and/or Business Excellence (e.g., MS Office software, MS Project, Qlikview, Spotfire, etc.).
• CMC experience preferred.

Skills

• Advanced project management principles and techniques
• MS Office software
• MS Project
• Qlikview
• Spotfire

Benefits

Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).

Pay

$124,500 - $236,500 USD

Schedule

Hybrid