Senior Scientist, Chemical Development and Manufacturing

Senior Scientist, Chemical Development and Manufacturing

Agios is seeking a talented and highly motivated Senior Scientist to join the Chemical Development & Manufacturing (CDM) team. This is a bench-forward, technically deep role for a scientist who thrives in the laboratory and wants to build expertise across the full spectrum of small molecule drug substance development — from early process design through technology transfer and clinical manufacturing.

Reporting to and closely supporting a CDM SME, you will serve as a key scientific contributor on an assigned small molecule program. Your primary responsibility is hands-on laboratory execution: generating the experimental data that drives process understanding, informs solid-state decisions, demonstrates scale-up feasibility, and enables the team to advance with confidence through each stage of development. You will be the bench anchoring the program.

What you will do:

• Process Chemistry — Bench to External Scaleup
• Solid State Development & Crystallization Science
• Engineering Support & Scale-Up Execution
• Data Management, Documentation & Regulatory Support

What you bring:

• Ph.D. in Organic Chemistry, Chemical Engineering, or a closely related discipline with 2–6+ years of pharmaceutical industry experience; or M.S. with 5–10+ years, with demonstrated laboratory leadership and increasing technical scope.
• Substantial hands-on synthetic organic chemistry experience at laboratory and, ideally, kilo-lab or production scale; proficiency in a broad range of reaction classes, purification methods, and analytical characterization techniques.
• Demonstrated experience in process chemistry — including reaction optimization, impurity identification and control, and scale-up evaluation — applied within a pharmaceutical development context.
• Familiarity with cGMP principles, ICH guidelines (Q3A/C, Q6A, Q8, Q11), and the documentation standards applicable to small molecule drug substance development.
• Strong laboratory technique, attention to detail, and a disciplined approach to experimental design, data interpretation, and scientific record-keeping.
• Effective written and verbal communication skills; ability to present complex experimental results clearly and concisely to colleagues, cross-functional partners, and external collaborators.
• Ability to work productively in a collaborative, fast-paced, matrixed environment with competing priorities and evolving program needs.

Preferred Qualifications

• Hands-on experience with structured DOE methodologies (e.g., JMP, Design-Expert) applied to process characterization, parameter ranging, or crystallization optimization.
• Practical experience with PAT tools (in-line Raman, IR, FBRM, PVM) in laboratory or scale-up settings, and familiarity with their application in process monitoring and control.
• Demonstrated kilo-lab or pilot-scale reactor experience, including familiarity with agitation, heat/mass transfer considerations, and scale-dependent process behaviors.
• Prior involvement in technology transfer campaigns to CMOs/CDMOs, including preparation of process descriptions, batch record templates, or engineering run protocols.
• Experience contributing to regulatory CMC documents (IND, CTA, Module 3 QOS sections) or development reports reviewed by regulatory agencies.
• Working knowledge of solid-state chemistry principles and practical experience with crystallization development, polymorph screening, or solid form characterization relevant to drug substance manufacture.
• Knowledge of process safety evaluation techniques (DSC calorimetry, ARC, reaction gas generation studies) applicable to pharmaceutical manufacturing scale-up.
• Experience with solid-state analytical techniques: XRPD, DSC/TGA, dynamic vapor sorption, PLM, or solid-state NMR for solid form characterization and stability assessment

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring…