Senior Director, Chemical Development & Manufacturing, CMC

Senior Director, Chemical Development & Manufacturing, CMC

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.

Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built.

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Agios Pharmaceuticals is searching for a strategic and scientifically accomplished Senior Director, Chemical Development & Manufacturing to join our CMC and Technical Operations team. This leader will set and execute drug substance development and manufacturing strategy across a portfolio centered on small‑molecule therapeutics while building fit‑for‑purpose capability for siRNA and oligonucleotide programs. The role will lead process development, scale‑up, technology transfer, external manufacturing, regulatory CMC, and lifecycle activities from candidate selection through commercialization.

The successful candidate will combine deep small‑molecule API expertise with meaningful experience in, or strong technical fluency across, nucleic acid therapeutics and will translate that breadth into reliable supply, sound decisions, and high‑performing partnerships.

• Lead small‑molecule drug substance strategy. Define phase‑appropriate CMC plans from candidate selection through commercial lifecycle, including route design, process optimization, scale‑up, control strategy, validation, and continuous improvement.
• Deliver robust API processes. Drive process chemistry and chemical engineering solutions that improve manufacturability, quality, yield, safety, sustainability, cost, and supply reliability.
• Provide end‑to‑end technical ownership. Establish physicochemical, solid‑form, impurity, raw‑material, and process understanding needed to support toxicology, clinical, registration, and commercial supply.
• Direct external development and manufacturing. Select, qualify, and govern CROs and CDMOs; set technical expectations; oversee campaign readiness and execution; and resolve complex technical, quality, schedule, and supply issues.
• Lead technology transfer and commercialization. Oversee process transfer, process characterization, PPQ readiness, validation, comparability, and lifecycle management across internal and external networks.
• Build siRNA and oligonucleotide capability. Shape phase‑appropriate development and manufacturing strategies for oligonucleotide drug substances, including siRNA.
• Apply modality‑specific technical judgment. Guide external partners across oligonucleotide synthesis, purification, conjugation, impurity control, analytical characterization, scale‑up, and supply strategy while recognizing platform‑specific risks and controls.
• Represent CDM on cross‑functional teams. Partner with Research, DMPK, Toxicology, Analytical Development, Formulation Development & Manufacturing, Quality, Regulatory Affairs, Supply Chain, Clinical Supply, and program leadership.
• Lead regulatory CMC delivery. Author, review, and approve drug substance content for INDs, IMPDs, NDAs, MAAs, health authority responses, and post‑approval submissions; support inspections and regulatory interactions.
• Support portfolio and business…