CMC Product Lead: Strategic Program Champion

RXinsider LTD.; Norwood, Northern (MA, KY); Hybrid; USD 184,000 - 330,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Paid time off including vacation and '

Global recharge days

Job summary

Moderna is seeking a CMC Product Lead to oversee and execute CMC strategies from first-in-human to pivotal studies, aligning program strategy with TPP/QTPP and translating plans into actionable tasks. The role interfaces with Resilience manufacturing sites and requires senior leadership, executive presence, and ability to navigate ambiguity.

The ideal candidate will have a strong track record in biotechnology/pharmaceutical CMC, with deep experience across development, manufacturing, supply

Qualifications

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

Responsibilities

• Define and communicate strategic CMC Development Plans for products in a therapeutic area, ensuring alignment with the TPP and QTPP.
• Translate platform and program strategy into actionable, achievable CMC tasks and milestones, prioritizing the portfolio in alignment with enterprise priorities.
• Serve as a key member of Program Team, representing CMC and working under the guidance of the Leadership Team (LT).
• Act as the primary point of accountability for the CMC plan, making critical decisions and serving as a resource to key leadership.
• Engage in technical discussions, own technical roadmap for program implementation and contribute to CMC sections of global regulatory submissions.
• Expert technical storytelling skills across multiple altitudes.
• Lead CMC team in discussions with key leadership, R&D teams, and internal governance bodies.
• Identify and address cross-functional gaps and risks, escalating issues appropriately to drive progress.
• Accountable for the strategy of the resource and financial management of the team, including budgeting, resource allocation and cost management
• Empower and delegate to team members/workstream leads, establishing credibility by diving into the appropriate level of detail when necessary.
• Engage the audience with the right content, balancing engagement based on risk and value.
• Build and maintain strong relationships across the organization, including with cross-functional stakeholders for facilitating strategic handshakes for effective lifecycle management.

Skills

Leadership

CMC Knowledge

Cross-functional leadership

Education

PhD

MS

BS/BA

Job description

Moderna is seeking a CMC Product Lead to oversee and execute CMC strategies from first-in-human to pivotal studies, aligning program strategy with TPP/QTPP and translating plans into actionable tasks. The role interfaces with Resilience manufacturing sites and requires senior leadership, executive presence, and ability to navigate ambiguity.

The ideal candidate will have a strong track record in biotechnology/pharmaceutical CMC, with deep experience across development, manufacturing, supply