CMC Product Lead — Strategic Drug Development & Leadership

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

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning benefits

Generous paid time off

Equity opportunities

Annual discretionary bonus

Job summary

Moderna Therapeutics is seeking a CMC Product Lead to oversee and execute CMC strategies across assets from FIH to pivotal studies. You will align program strategy with TPP/QTPP and translate it into actionable CMC plans, serving as a key interface with Resilience manufacturing sites and senior leadership.

Ideal candidates bring 10+ years PhD/MS/BS combo in biotech with proven cross-functional leadership, and a track record in regulatory submissions and technical storytelling across altitudes.

Qualifications

• Advanced degree with significant experience in CMC and product development.
• Proven leadership in cross-functional biotech/pharma teams.
• Strong ability to translate strategy into actionable CMC plans.

Responsibilities

• Define and communicate strategic CMC Development Plans aligned with TPP and QTPP.
• Translate program strategy into actionable CMC tasks and milestones.
• Represent CMC in Program Team and interact with Leadership Team.
• Own the CMC plan and make critical decisions for the program.

Skills

CMC Strategy

Leadership

Cross-functional teams

Regulatory submissions

Education

PhD

MS

BS/BA

Job description

Moderna Therapeutics is seeking a CMC Product Lead to oversee and execute CMC strategies across assets from FIH to pivotal studies. You will align program strategy with TPP/QTPP and translate it into actionable CMC plans, serving as a key interface with Resilience manufacturing sites and senior leadership.

Ideal candidates bring 10+ years PhD/MS/BS combo in biotech with proven cross-functional leadership, and a track record in regulatory submissions and technical storytelling across altitudes.