- Lead project management efforts for CMC product development from First in Human through Transfer to Supply
- Manage end-to-end CMC development projects, including projects of significant complexity
- Drive cross-functional teams and lead by influence to develop strategies and ensure execution
- Guide creation, approval, and execution of integrated project plans
- Develop CMC strategies optimized for the portfolio
- Build and maintain project schedules and critical project information
- Integrate activities across key functional areas and proactively identify risks
- Communicate project information to team, management, and cross-departmental stakeholders
- Leverage relationships and networks to improve team dynamics and remove obstacles
- Guide teams through corporate governance and business requirements
- Lead key team meetings, create agendas, ensure participation, provide project management insights, and follow up on progress
- Participate in CIPM and GPAM departmental initiatives and workstreams
- Mentor, coach, and oversee Specialist and Senior Specialist project managers
- Support multiple projects with team management, stakeholder management, and governance preparation
Requirements
- Bachelor’s degree required; concentration in a scientific or applied discipline preferred
- Minimum of five (5) years of experience in project management or a related role required
- Experience planning and executing strategies for drug/vaccine product registration and commercialization/life-cycle management
- Ability to translate knowledge and expertise to other development teams and areas
- Strong oral and written communication skills
- Ability to appropriately raise issues to teams and management
- Ability to keep team members, departmental colleagues, and management apprised of project status and issues
- Ability to serve as a resource for colleagues and program teams
- Effective interpersonal skills and ability to work collaboratively across teams and networks
- Ability to foster cooperation and use differing perspectives to generate ideas
- Ability to succeed in a dynamic environment and respond flexibly to changing priorities
- Advanced scientific degree (e.g., MS, MBA, Ph.D., PharmD) preferred
- Project management certification (PMP) and/or formal project management coursework/training strongly preferred
- No visa sponsorship
- United States and Puerto Rico residency required
- Valid driving license not required
Core Competencies
Demonstrates expertise in project management for CMC product development, including strategy planning, execution, and cross-functional team leadership. Proficient in managing complex projects, fostering collaboration, and ensuring effective communication across stakeholders.
Highest-signal resume keywords
- Project Management Certification (PMP)
- CMC Product Development
- Drug/Vaccine Product Registration
- Cross-Functional Team Leadership
- Stakeholder Management
Hard Skills
- Project Management
- Strategic Planning
- Risk Identification
- Project Scheduling
- Governance Preparation
Soft Skills
- Strong Oral Communication
- Effective Interpersonal Skills
- Collaborative Work
- Mentoring and Coaching
- Flexibility in Dynamic Environments
Certifications & Qualifications
- Project Management Certification (PMP)
Industry Keywords
- CMC Development
- Life-Cycle Management
- First in Human
- Integrated Project Plans
- Corporate Governance