CMC Strategy & Operations Executive Director

Flagship Pioneering; Boston (MA); On-site; USD 228,000 - 313,500; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Job summary

Flagship Pioneering in Boston seeks an Executive Director, CMC to lead CMC functions including Drug Substance Development and Regulatory CMC. The role requires a proven track record of driving CMC strategy across multiple programs, managing budget and risk, and ensuring compliance with regulatory expectations. Ideal candidates hold a PhD in a relevant field with over 15 years of CMC experience and a robust understanding of AI/ML processes. The position offers competitive salary and comprehensive benefits.

Qualifications

• 15+ years of progressive CMC experience, with at least 5 years in senior leadership.
• Experience in leading technology transfer and managing CDMOs/CROs.
• Executive presence with strong communication skills.

Responsibilities

• Lead CMC functions including Drug Substance Development and Regulatory CMC.
• Build, scale, and manage the CMC organization.
• Engage key stakeholders and establish CMC development paradigms.

Skills

Deep hands‑on expertise in small molecules and biologics

Strategic CMC leadership

Regulatory dossier filing experience

Ability to drive CMC execution across multiple programs

Education

PhD in a relevant scientific discipline

Tools

AI/ML and digital process development tools

Job description

Flagship Pioneering in Boston seeks an Executive Director, CMC to lead CMC functions including Drug Substance Development and Regulatory CMC. The role requires a proven track record of driving CMC strategy across multiple programs, managing budget and risk, and ensuring compliance with regulatory expectations. Ideal candidates hold a PhD in a relevant field with over 15 years of CMC experience and a robust understanding of AI/ML processes. The position offers competitive salary and comprehensive benefits.