CMC Product Strategy Lead: Global Drug Development

Moderna; Norwood (MA); Vor Ort; USD 184.000 - 330.000; Vollzeit

Benefits dieser Stelle

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings & investments

Location-specific perks

Zusammenfassung

Moderna is seeking a CMC Product Lead to oversee development plans from first-in-human to pivotal studies, ensuring alignment with TPP and QTPP. You will translate program strategy into actionable CMC tasks, interface with Resilience manufacturing sites, and drive governance with executive stakeholders.

The role requires deep drug development knowledge, executive presence, and the ability to navigate ambiguity while leading through complex, high-growth programs in a collaborative, fast-paced

Qualifikationen

• PhD with 10+ years, MS with 12+ years, or BS/BA 15+ years of relevant experience.
• Proven leadership experience in CMC or product development within biotech/pharma.
• Strong knowledge of CMC-related activities including Development, Manufacturing, Supply Chain, Quality, Process Development, and Regulatory.
• Demonstrated ability to lead cross-functional teams and manage complex projects with strategic/operational impact.

Aufgaben

• Define and communicate strategic CMC Development Plans aligned with TPP and QTPP.
• Translate platform and program strategy into actionable CMC tasks and milestones.
• Serve as a key Program Team member representing CMC under LT guidance.
• Be the primary accountability for the CMC plan and critical decisions for leadership.
• Engage in technical discussions and own the technical roadmap for program implementation.
• Provide expert technical storytelling across multiple altitudes.
• Lead CMC team discussions with leadership, R&D, and governance bodies.
• Identify and address cross-functional gaps and risks, escalating issues to drive progress.
• Manage resource and financial strategy for the team, including budgeting and allocation.
• Delegate to team leads and maintain credibility by depth where needed.
• Engage the audience with content balance based on risk and value.
• Build strong relationships across the organization for lifecycle management.

Kenntnisse

CMC Leadership

Strategic Planning

Cross-functional Leadership

Regulatory Knowledge

Technical Storytelling

Ausbildung

PhD

MS

BS/BA

Jobbeschreibung

Moderna is seeking a CMC Product Lead to oversee development plans from first-in-human to pivotal studies, ensuring alignment with TPP and QTPP. You will translate program strategy into actionable CMC tasks, interface with Resilience manufacturing sites, and drive governance with executive stakeholders.

The role requires deep drug development knowledge, executive presence, and the ability to navigate ambiguity while leading through complex, high-growth programs in a collaborative, fast-paced