Program Manager, CMC Portfolio Management

About the role

The 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 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.

Responsibilities

• Independently provide advanced project management support to low/standard complexity (e.g. early-late stage) 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 a single large or several small cross-functional process improvement projects. Converts goals to tasks and coordinates activities to meet goals. Estimates and manages requirements to achieve defined objectives. Execute against defined objectives and keep management informed of progress and achieved project milestones.
• Apply 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.
• Provide general training support, administration and guidance regarding project management practices and systems.
• Establish and maintain strong network within department and external stakeholders. Interacts with all levels of employees in support of project coordination.
• Assesses performance against plans, processes, and practices to determine effectiveness and recommend areas for process improvement to Manager/Director within the CMC Portfolio Management group.

Qualifications & Requirements

• Bachelors degree required in a technical or scientific related discipline and 6+ years professional work experience in the pharmaceutical or biotech industry; or Masters degree with 4+ years of work experience; or Doctorate degree 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 preferred (e.g. Project Management Professional, LEAN Six Sigma, etc.).
• Must be self-directed and work well in a team environment, be able to work on multiple projects concurrently and meet commitments, possess excellent oral and written communication skills, be process-oriented, convert goals to tasks and define estimates on time and requirements to achieve goal objectives, and demonstrate initiative.
• The incumbent must be able to discern the difference between general vs. confidential/sensitive reporting information and act accordingly.
• Experience/Awareness in the tools and techniques of Project Management and /or Business Excellence desired.
• Proficient technology skills (e.g., MS Office software, MS Project, Qlikview, Spotfire, etc.) required.
• CMC experience preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.