Manager, CMC Project Management
The Manager, CMC Project Management will report to the Head of CMC Project Management and will work closely with technical and functional area members, vendors, and contract laboratories to develop CMC plans to progress mRNA therapeutics from bench to clinic, coordinate and track the progress of CMC plans as established by defined milestones and objectives.
- Serve as an integral member of project teams, work with Moderna Therapeutic areas and Partners to progress CMC activities and generate/execute CMC timelines.
- Work with clinical teams to project drug needs, drug presentation and batch requirements.
- Work with Supply Chain to manage manufacturing scheduling.
- Coordinate meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.
- Manage team documentation.
- Communicate effectively to stakeholders. Represent the CMC Team when communicating externally.
- Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing.
- Track project tasks and efforts associated with process development, analytical development, pharmaceutical development, manufacturing, quality and supply chain.
- Provide support to Management in assessing resource needs to achieve timelines and quality milestones.
- Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
- Develop tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers.
- Publish clear and concise meeting agendas, notes and action items.
- Degree in a scientific discipline with a minimum of 5 years of experience in a pharmaceutical or biotechnology environment managing projects in CMC areas.
- Demonstrated understanding of the drug development process from research through a commercial product including an understanding of the interdependencies of functional groups.
- Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge with shared work environments.
- Experience in GMP production, process development, scale-up engineering, analytical method development, formulation, and characterization.
- Demonstrated experience managing interdisciplinary development teams; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.