Scientist, Process Analytics, Synthetic Molecule Process Development

3316 Takeda Development Center Americas•Cambridge, MA

1d•Onsite

About The Position

Takeda is seeking a Scientist, Process Analytics, to support process chemistry and engineering efforts in the Process Analytics Group for Synthetic Molecule Process Development (Drug Substance). The role focuses on specialized off-line analytical method development to support route scouting, reaction optimization, and mechanistic understanding for synthetic molecules. The scientist provides theoretical and conceptual input to research assignments, independently plans and executes unit-operation characterization and optimization experiments, and provides significant or sole technical leadership on projects or complex studies. The position reports to the Head, Process Analytics, Synthetic Molecule Process Development, and is based in Cambridge, Massachusetts. The scientist designs and executes drug-substance process development analytical activities, including phase-appropriate method development, preliminary isolation and identification of process impurities, reaction kinetics and mechanism studies, and data management. The role collaborates with process chemistry, analytical development, and engineering teams on process optimization, scale-up, and technology transfer. It also supports process troubleshooting, in-process controls, technology innovation, and data-driven improvements to process efficiency and product quality. The position contributes technical leadership across projects and functional areas, communicates findings within Chemistry, Manufacturing & Controls (CMC) and project teams, and helps advance analytical technologies and data platforms. The role may require 5–10% travel and requires the ability to work in a laboratory setting.

Requirements

Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related pharmaceutical science and 5 or more years of relevant industry experience; or a master's degree in one of these fields and 3 or more years of relevant industry experience; or a Ph.D. in one of these fields and 0 or more years of relevant industry experience.
Working knowledge of modern analytical methods for small-molecule pharmaceuticals, particularly HPLC, GC, and LC-MS, and associated analytical software and data-processing platforms such as Empower or OpenLab.
Good understanding of synthetic organic chemistry.
Ability to troubleshoot critical issues, determine causes, and identify workable solutions.
Ability to work effectively in highly cross-functional teams and across global line functions.
Clear and concise communication skills, including technical writing for internal technical documents; ability to adapt communication to the audience and communicate issues promptly.
Time-management, prioritization, and organizational skills, including the ability to manage multiple tasks simultaneously.
Ability to capture and share organizational knowledge and improve solutions, processes, and deliverables through shared information and experience.
Ability to manage time and internal and external resources, including vendors, within individual, departmental, and corporate goals and timelines.
Demonstrated involvement in the professional community, evidenced by presentations of scientific posters or lectures at professional conferences or events.
Ability to interpret complex experimental results and integrate data produced by other disciplines.
Ability to work in a laboratory setting.
Proficiency in using literature-searching techniques to solve technical problems.

Responsibilities

Design and execute drug-substance process development analytical activities, including phase-appropriate method development, preliminary isolation and identification of process impurities, reaction kinetics and mechanism studies, and data management.
Collaborate with drug-substance process chemistry, analytical development, and engineering teams to design and execute experiments for process optimization, scale-up, and technology transfer.
Perform analytical testing for small-molecule pharmaceuticals, including HPLC, LC-MS, GC, Karl Fischer, NMR, and solid-state characterization such as XRPD, DSC, TGA, and DVS, as needed.
Identify critical in-process-control issues and develop appropriate in-process-control methods.
Provide analytical expertise to troubleshoot process-related issues and implement corrective actions.
Support method development for innovation and technology teams, including Process Analytical Technology and high-throughput experimentation teams.
Analyze and interpret analytical data to assess process performance, identify trends, and inform improvements to process efficiency and product quality.
Monitor emerging trends and advancements in analytical chemistry and process optimization, and identify opportunities for continuous improvement in techniques, processes, and systems.
Advance technology cross-functionally for the Process Analytics team and Synthetic Molecule Process Development.
Contribute to consolidating analytical data platforms so chemists and engineers can access data, accelerate processing, and integrate results.
Lead or influence others on complex or multiple projects and functional areas, and support scientific and technical improvement initiatives.
Define approaches and methodologies for complex technical challenges and identify vendors and develop relationships to access technologies needed to meet pipeline goals.
Understand project timelines and deliverables, and plan and coordinate work with departmental, functional, and external stakeholders.
Provide technical leadership to project teams within the area of expertise and contribute independently to one or more projects.
Review, interpret, and communicate data across CMC and project teams.
Plan and implement solutions to technical problems, independently design and execute experiments, and report results.
Integrate scientific and technical efforts around cross-functional issues.