Senior Director, CMC: Small Molecules & Oligos

Agios Pharmaceuticals Inc.; Cambridge (MA); Hybrid; USD 230,000 - 344,000; Full time

Job summary

Agios Pharmaceuticals seeks a strategic Senior Director, Chemical Development & Manufacturing (CMC) to set and execute drug substance development strategy across small‑molecule programs while building capability for siRNA and oligonucleotide therapies.

You will lead process development, scale‑up, tech transfer, external manufacturing, regulatory CMC, and lifecycle activities from candidate selection through commercialization.

Qualifications

• Ph.D. in chemistry or related field with typically 15+ years of pharma/biotech experience.
• Deep expertise in small‑molecule drug substance process development and manufacturing.
• Demonstrated leadership in route design, impurity control, process scale‑up, technology transfer, validation, and lifecycle management.

Responsibilities

• Define phase‑appropriate CMC plans from candidate selection through commercialization, including route design and process optimization.
• Drive robust API processes, aiming to improve manufacturability, yield, cost, safety, and supply reliability.
• Provide end‑to‑end technical ownership across analytic and manufacturing spaces to ensure supply for toxicology, clinical, regulatory, and commercial needs.
• Direct external development and manufacturing by selecting and governing CROs/CDMOs and overseeing readiness and execution.

Skills

Leadership

CMC strategy

Process development

Regulatory experience

Cross-functional leadership

Education

PhD in Chemistry or related field

Job description

Agios Pharmaceuticals seeks a strategic Senior Director, Chemical Development & Manufacturing (CMC) to set and execute drug substance development strategy across small‑molecule programs while building capability for siRNA and oligonucleotide therapies.

You will lead process development, scale‑up, tech transfer, external manufacturing, regulatory CMC, and lifecycle activities from candidate selection through commercialization.