Senior Scientist, Chemical Development and Manufacturing

About the role

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.

Responsibilities

• Process Chemistry — Bench to External Scaleup Design, execute, and interpret laboratory experiments to develop robust, scalable synthetic routes for small molecule drug substances; apply mechanistic understanding to guide reaction optimization and troubleshooting.

• Conduct structured process optimization studies (including DOE-driven parameter screening and Design Space mapping) to define critical process parameters and establish proven acceptable ranges.

• Generate high-quality impurity profiles; identify, synthesize, and characterize process-related impurities; develop and implement control strategies to meet ICH Q3A/Q3C requirements.

• Document and transfer to external CDMOs kilo-lab and pilot-scale reactions under GMP or GMP-like conditions; evaluate equipment performance, mixing dynamics, heat transfer behavior, and process scalability with increasing batch sizes.

• Investigate and resolve process-related manufacturing deviations, atypical results, and OOS observations through systematic root cause analysis and corrective action experiments at the bench.

• Explore and apply advanced synthetic technologies to accelerate development — including continuous flow chemistry, in-line process analytics (PAT), and computational tools for reaction and process modeling.

• Solid State Development & Crystallization Science — Conduct polymorph, salt, co-crystal, and solvate screening campaigns to identify and evaluate drug substance solid forms with appropriate physical, chemical, and stability properties for development.

• Design and execute crystallization development studies — including solvent system evaluation, antisolvent addition, seeding strategies, and cooling profiles — to deliver a controlled, reproducible, and scalable crystallization process.

• Characterize solid forms using standard analytical techniques (XRPD, DSC, TGA, PLM, dynamic vapor sorption, NMR) and interpret data in the context of form selection and process design.

• Develop particle engineering strategies to achieve target particle size distribution, morphology, and bulk density requirements critical for downstream processing and formulation compatibility.

• Assess solid form stability under stressed and ICH-aligned conditions; support selection of the preferred commercial form through integrated analysis of processability, stability, and bioavailability data.

• Maintain and transfer crystallization processes to CDMO partners in collaboration with the AD; provide technical input during scale-up and troubleshoot crystallization-related issues observed at manufacturing scale.

• Engineering Support & Scale-Up Execution — Support technology transfer of laboratory processes to CDMOs and CROs by preparing detailed process descriptions, batch manufacturing records, and engineering run protocols in collaboration with the AD program lead.

• Evaluate production-scale equipment relevant to drug substance manufacture — including stirred tank reactors, agitation systems, filtration equipment, and drying technologies — providing bench-scale data to inform equipment selection and process fit.

• Participate in and provide scientific support for engineering runs and cGMP manufacturing campaigns at CDMO sites; assist in the assessment of process performance against development data and identify opportunities for process improvement.

• Apply process safety principles in laboratory and kilo-lab work; conduct reaction hazard assessments (e.g., DSC-based calorimetry, gas generation) and incorporate findings into scale-up risk evaluations.

• Contribute to the development of process control strategies, in-process testing specifications, and acceptance criteria aligned with quality-by-design (QbD) principles and ICH Q8/Q11 guidance.

• Data Management, Documentation & Regulatory Support — Maintain thorough, contemporaneous electronic laboratory notebooks (ELN) and generate well-organized experimental reports that accurately capture methods, data, observations, and scientific conclusions.

• Contribute to the authorship of development reports, process descriptions, technology transfer packages, and CMC regulatory sections (IND, CTA, QOS, NDA Module 3 / MAA Module 3) under the direction of the CDM SME.

• Present experimental results and scientific interpretations to the CDM team, cross-functional CMC sub-teams, and external partners in a clear, organized, and data-driven manner.

Requirements

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.

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.
• Experience with kilo-lab or pilot-scale reactor experience, including familiarity with agitation, heat/mass transfer considerations, and scale-dependent process behaviors.
• Previous 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.
• Knowledge of solid-state chemistry principles and practical experience with crystallization development, polymorph screening, or solid form characterization relevant to drug substance manufacture.
• Working 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.

Skills

• Hands-on experience with advanced synthetic technologies such as continuous flow chemistry, in-line process analytics (PAT), and computational tools for reaction and process modeling.
• Strong background in solid-state chemistry principles and practical experience with crystallization development, polymorph screening, or solid form characterization relevant to drug substance manufacture.
• Proficiency in 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.

Benefits

Deliberate Development. Your professional growth as one of our top priorities.

Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.

Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.

Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.

Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.

Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.