Senior Director, CMC Program Management

4 weeks ago

Norwood Young America, Minnesota, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Associate Director, CMC Program Management to lead pivotal work focusing on the design and comprehensive management of CMC program integrated project plans.

The ideal candidate will have a background in science with prior experience in Manufacturing, Quality, Process Development, and/or Supply Chain organizations.

This is an onsite role based in Moderna's Technology Center campus in Norwood, MA.

Key Responsibilities
  • Leverage previous experience within CMC product development and commercialization to integrate between multiple functional areas, including Tech Dev, Manufacturing, Regulatory, Quality, and Supply Chain.
  • Lead cross-functional teams or projects characterized by complexity, risk, and integration requirements across multiple functions, ensuring adherence to broader organizational goals.
  • Influence high-level decision-making within the organization by providing comprehensive project insights and strategic recommendations.
  • Oversee the CMC project plan to align with strategic goals and ensure timely execution.
  • Develop project plans that integrate cross-functional inputs and support strategy execution.
  • Manage risk registers by identifying risks and implementing mitigation strategies.
  • Ensure action items from team meetings are completed, upholding team accountability.
  • Organize and lead team meetings, producing concise materials to communicate key points.
  • Provide data analysis to support strategic decisions and direction setting.
  • Track project milestones, report progress, and keep stakeholders informed.
  • Formulate plans for risk mitigation and scenario planning for potential challenges.
  • Oversee project budgets, ensuring alignment with financial objectives.
  • Lead Project Management processes, including reviews, goal setting, and commercialization strategies.
  • Drive the enhancement of Project Management practices for organizational effectiveness.
  • Advocate for resources to impact long-term organizational objectives, effectively managing external vendors and ensuring alignment with organizational standards.
  • Participate in and contribute to company-wide improvement initiatives.
Requirements
  • Bachelor's or Master's degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline.
  • 12 years of relevant experience with a Bachelor's degree or 10 years of relevant experience with a Master's degree.
  • Project Management Professional (PMP) certification is preferred.
  • Previous experience with CMC product development and commercialization is preferred.
  • Familiarity with CMC technical processes and the overall drug development process.
  • Strong project management skills with an agile approach to system development.
  • Excellent communication skills and the ability to influence without authority.
  • Proven experience in risk register maintenance and action log management.
  • Proficiency in facilitating meetings and drafting presentation materials.
  • Ability to lead contingency planning and scenario analyses.
  • Advanced PowerPoint, SmartSheet, and MS Project skills.
  • Evidence of advanced problem-solving, innovative thinking, strategic planning to deliver creative solutions.
  • Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.
  • Excellent organizational, communication, and analytical skills with a keen attention to detail.
  • Outstanding interpersonal skills to form and maintain strong relationships.
  • Willingness and dedication to go above and beyond in pursuit of team goals.

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