CMC Strategy & Operations Executive Director

Flagship Pioneering; Boston (MA); Vor Ort; USD 228.000 - 313.500; Vollzeit

Benefits dieser Stelle

Healthcare coverage

Annual incentive program

Retirement benefits

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Deep hands‑on expertise in small molecules and biologics

Strategic CMC leadership

Regulatory dossier filing experience

Ability to drive CMC execution across multiple programs

Ausbildung

PhD in a relevant scientific discipline

Tools

AI/ML and digital process development tools

Jobbeschreibung

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.