Associate Director, Chemical Development and Manufacturing

Associate Director, Chemical Development and Manufacturing

Who we are:

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. To learn more, visit  and follow Agios on Linked In and X.

Agios is seeking an experienced and dynamic Associate Director to join the Chemical Development & Manufacturing (CDM) team
. This is a high-impact, senior contributor and technical leadership role that sits at the nexus of process chemistry, external manufacturing, regulatory science, and cross-functional program execution.

As the Subject Matter Expert (SME) for a priority small molecule program, you will own the drug substance technical strategy from clinical manufacturing through registration, validation, commercial launch, and post-approval life-cycle management. You will serve as the primary CDMO-facing technical authority, CMC sub-team lead, and internal advocate for process understanding and supply continuity across global regulatory jurisdictions.

• Serve as the DS technical SME for an assigned small molecule program, owning the end-to-end process chemistry strategy from clinical Phase through regulatory submission, validation, commercial launch, and life‑cycle management.
• Lead process design, optimization, scale‑up, technology transfer, and process validation campaigns at external CDMO sites; ensure manufacturing outcomes are robust, reproducible, and cGMP‑compliant.
• Identify and systematically close process knowledge gaps to ensure understanding is commensurate with the program's stage of development and aligned to ICH Q8/Q9/Q10/Q11 expectations.
• Provide technical troubleshooting and root cause analysis for manufacturing deviations, OOS investigations, and process‑related atypical results in collaboration with CDMO quality and operations teams.
• Champion the application of advanced development tools including Design of Experiments (DOE), process analytical technology (PAT), flow chemistry, computational process

• Act as the primary technical point of contact with CDMOs and CROs for drug substance development activities; direct and review technical work conducted externally, including batch records, development reports, analytical data packages, and validation protocols.
• Manage external partner performance against technical deliverables, timelines, and quality standards; proactively elevate risks and develop mitigation strategies in collaboration with cross‑functional and CDMO leadership.
• Evaluate manufacturing equipment, engineering capabilities, and production processes at CDMO sites to ensure suitability for clinical and commercial scale manufacturing; provide SME input on capital equipment decisions and facility qualification activities.
• Support the assessment and selection of CDMOs for new programs and technology transfer campaigns; conduct technical due diligence and gap analyses for prospective external manufacturing partners.

• Serve as the drug substance technical lead on the CMC sub‑team, providing authoritative input to the integrated development plan, regulatory strategy, and program timelines.
• Collaborate closely with Analytical Development, Formulation Development, Quality, Regulatory Affairs, Supply Chain, and Clinical Operations to ensure seamless CMC execution across all program milestones.
• Lead CMC‑related risk assessments, FMEA exercises, and technical review boards; provide expert…