CMC Product Strategy Leader

Biopharma Careers

Norwood (KY)

On-site

USD 184,000 - 330,000

Full time

10 days ago
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Benefits offered by this job

Competitive healthcare
Well-being resources
Paid time off
Equity options

Job summary

Moderna is seeking a CMC Product Lead to define and execute CMC strategies across assets, aligning with TPP/QTPP and translating program plans into actionable tasks for global development.

You will lead cross-functional teams, manage budgets, mentor staff, and drive critical decisions with executive presence in a fast-paced biotech setting. Experience with regulatory submissions will be valued.

Qualifications

  • PhD/MS/BS with extensive biotechnology/pharma experience.
  • Proven leadership in CMC or product development.
  • Strong knowledge of CMC-related activities.
  • Ability to lead cross-functional teams and manage strategic projects.

Responsibilities

  • Define and communicate strategic CMC Development Plans.
  • Translate platform strategy into actionable CMC tasks and milestones.
  • Serve as a key member of Program Team representing CMC.
  • Act as the primary accountability for the CMC plan and decisions.
  • Engage in technical discussions, own technical roadmap for program implementation.
  • Expert technical storytelling across multiple altitudes.
  • Lead CMC team in discussions with leadership and R&D.
  • Identify cross-functional gaps and escalate risks to drive progress.
  • Manage resource and financial strategy for the team, including budgeting.
  • Delegate to team leads while maintaining credibility.
  • Engage stakeholders with content balanced by risk and value.

Skills

Leadership experience
Cross-functional teams
CMC knowledge
Strategic planning

Education

PhD in relevant field
MS in relevant field
BS/BA in relevant field

Job description

Moderna is seeking a CMC Product Lead to define and execute CMC strategies across assets, aligning with TPP/QTPP and translating program plans into actionable tasks for global development.

You will lead cross-functional teams, manage budgets, mentor staff, and drive critical decisions with executive presence in a fast-paced biotech setting. Experience with regulatory submissions will be valued.

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