Pioneering Medicines: Executive Director, CMC (Chemistry, Manufacturing & Controls)

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

Position Summary

We are seeking an Executive Director, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This senior leadership role operates at the intersection of science, strategy, and operations—requiring the ability to set direction across a complex multimodality pipeline, and build CMC function as a competitive advantage for Pioneering Medicines.

Responsibilities

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement.
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation.
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; maintain a forward‑looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs.
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI‑driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio.
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross‑functional trade‑offs, and ensure portfolio decisions reflect both scientific rigor and operational reality.
• Oversee CMC handoffs and establishing fit‑for‑purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed.
• Serve as an ambassador of PM for external stakeholders and industry as a whole.

Requirements

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs.
• Deep hands‑on expertise in small molecules and biologics. Expertise preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies.
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability owning CMC strategy and execution across a multi‑program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines.
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites.
• Thought leadership in innovation, including novel delivery, high‑throughput process development, and platform‑based approaches to elevate program / portfolio value.
• Strong understanding of AI/ML, digital process development tools, and data‑driven manufacturing platforms to improve development speed and efficiency.
• Executive presence and demonstrated ability to influence and align cross‑functional PM and platform company leaders; strong communicator who can translate complex CMC strategy and risk for non‑specialist audiences.
• Experience partnering with GxP Quality to establish quality systems appropriate for a development‑stage organization, including SOPs, change control, and deviation management in a GxP environment.
• Entrepreneurial builder energized by creating structure in ambiguous, fast‑moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information.
• Collaborative, low‑ego leadership style with genuine investment in team development and cross‑functional relationships.

Benefits & Compensation

• Salary range $228,000 - $313,500.
• Healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits.