Senior Specialist – CMC Program Management
| Company | Moderna |
|---|---|
| Location | Norwood, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- Education: Bachelor’s or Master’s in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline.
- Experience: 5 years of relevant experience with a Bachelor’s degree or 2 years of relevant experience with a Master’s degree.
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.
- Create and oversee the CMC project plan to align with program goals and ensure timely execution.
- Develop project plans that integrate cross-functional inputs and support strategy execution.
- Manage the risk register 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.
- Contribute to the enhancement of Project Management practices for organizational effectiveness.
- Participate in and contribute to company-wide improvement initiatives.
Preferred Qualifications
- Project Management Professional (PMP) certification.
- Previous experience with CMC product development and commercialization.
- 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 to deliver creative solutions.
- Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.
- Excellent organizational, communication, and analytical skills with 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.
- Desire to understand and learn new technology.