CMC Product Strategy Lead for Global Programs

BioSpace; Norwood (MA); Hybrid; USD 184,000 - 330,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Generous time off

Job summary

Moderna is seeking a CMC Product Lead to oversee and execute CMC strategies for multiple assets from FIH to pivotal studies. You will align program strategy with TPP/QTPP and translate Core Team plans into actionable CMC work, interfacing with resilience manufacturing sites.

The role requires deep drug-development knowledge, leadership, and the ability to communicate complex messages clearly. This position supports a hybrid in-office model with senior leadership involvement.

Qualifications

• PhD/MS/BS with extensive leadership in CMC or product development in biotech/pharma.
• Strong knowledge of CMC activities: development, manufacturing, quality, regulatory.
• Proven ability to lead cross-functional teams on complex projects with strategic impact.

Responsibilities

• Define and communicate strategic CMC development plans aligned with TPP/QTPP.
• Translate strategy into actionable CMC tasks and milestones.
• Serve on Program Team and represent CMC under Leadership Team guidance.
• Be the primary accountable owner of the CMC plan and decision-maker for the program.
• Lead technical discussions and contribute to CMC sections of global regulatory submissions.
• Demonstrate technical storytelling across multiple levels of the organization.
• Lead the CMC team in governance discussions with leadership and R&D.
• Identify and address cross-functional gaps and risks; escalate as needed.
• Own budgeting, resource allocation, and cost management for the team.
• Empower team members and delegate to leads with appropriate detail.
• Present content to stakeholders balancing risk and value.
• Foster relationships across the organization for lifecycle management.

Skills

Leadership

Cross-functional collaboration

Strategic thinking

Communication

Executive presence

Education

PhD with 10+ years

MS with 12+ years

BS/BA 15+ years

Job description

Moderna is seeking a CMC Product Lead to oversee and execute CMC strategies for multiple assets from FIH to pivotal studies. You will align program strategy with TPP/QTPP and translate Core Team plans into actionable CMC work, interfacing with resilience manufacturing sites.

The role requires deep drug-development knowledge, leadership, and the ability to communicate complex messages clearly. This position supports a hybrid in-office model with senior leadership involvement.