Scientist, Process Analytics, Synthetic Molecule Process Development

Takeda•Cambridge, MA

3d•$116,000 - $182,270•Onsite

About The Position

Takeda is hiring a Scientist, Process Analytics, in its Process Analytics Group within Synthetic Molecule Process Development (Drug Substance) in Cambridge, Massachusetts. The role supports process chemistry and engineering through specialized expertise in off-line analytical method development for route scouting, reaction optimization, and understanding mechanisms for synthetic molecules. It also provides theoretical and conceptual input to the design, development, and execution of project research assignments. The scientist independently plans and executes most unit-operation characterization and optimization experiments within their area of expertise, while developing awareness of other unit operations. The position provides significant or sole technical leadership on projects or complex studies, identifies process and study challenges proactively, and proposes resolutions. The role reports to the Head, Process Analytics, Synthetic Molecule Process Development. The scientist collaborates across process chemistry, analytical development, engineering, innovation, and technology teams to support process optimization, scale-up, technology transfer, analytical innovation, and data integration. The position involves interpreting and communicating data across CMC and project teams, coordinating work with stakeholders, and contributing to technical and scientific improvements.

Requirements

Bachelor’s degree in chemistry, biology, pharmacy, engineering, or a related pharmaceutical science and at least 5 years of relevant industry experience; or a master’s degree in one of these fields and at least 3 years of relevant industry experience; or a PhD in one of these fields and 0 or more years of relevant industry experience.
Working knowledge of modern analyses 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 or problems, determine causes, and identify workable solutions.
Ability to work effectively in highly cross-functional teams and across global line functions.
Clear, concise communication skills, including documenting issues and concerns, adapting communication style to the audience, timely communication with a supervisor, and technical writing for internal technical documents.
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 information and contributed experience, theories, deliverables, and models.
Ability to manage time within individual, departmental, and corporate goals and timelines, and to manage internal and external resources such as vendors.
Demonstrated involvement in the professional community, evidenced by presenting scientific posters or lectures at professional conferences or events.
Ability to interpret results of complex experiments and integrate data produced by other disciplines.
Ability to work in a laboratory setting.
Proficiency in 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 using methods and techniques such as HPLC, LC-MS, GC, KF, NMR, and solid-state characterization when needed.
Identify critical in-process-control issues and develop appropriate IPC 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 (PAT) and High Throughput Experimentation (HTE) teams.
Analyze and interpret analytical data to assess process performance, identify trends, and make data-driven decisions to improve process efficiency and product quality.
Monitor developments in analytical chemistry and process-optimization methodologies and identify opportunities for continuous improvement in analytical techniques, processes, and systems.
Work cross-functionally to advance technology and continued innovation for the Process Analytics team and Synthetic Molecule Process Development.
Consolidate analytical data on platforms so chemists and engineers can access it, accelerate processing, and integrate results.
Lead or influence others while contributing to complex or multiple projects and functional areas.
Support scientific and technical improvement initiatives within the function and potentially across functions.
Help ensure a productive, development-rich environment.
Define novel or complex approaches and methodologies for solving technical challenges.
Identify vendors and build relationships to obtain access to technologies needed to deliver pipeline goals.
Understand project timelines and deliverables, and plan and coordinate project work with departmental, functional, and external stakeholders.
Provide technical leadership to project teams within the area of expertise.
Contribute independently and significantly to project work, potentially across multiple projects within the functional area.
Review, interpret, and communicate data cross-functionally within CMC and project teams.
Plan and implement resolutions to technical problems and issues.
Independently design and execute experiments and report results.
Integrate scientific and technical efforts addressing cross-functional issues.