Scientist, Process Analytics, Synthetic Molecule Process Development
Takeda
Summary
Join Takeda as a Scientist, Process Analytics where you will provide support for process chemistry and engineering efforts through specialized expertise in off-line analytical method development aimed at route scouting, optimizing reactions and understanding mechanisms for synthetic molecules.
Job description
You will also provide theoretical and conceptual input to the design, development, and execution of research assignments for specific projects. Additionally, you will independently plan and execute most unit operation characterization and optimization experiments within their area of expertise and develop an awareness of unit operations in other areas.
This role is responsible for significant or sole technical leadership within projects or complex studies, proactively identifying process or study issues and challenges, and proposing potential resolutions.
How you will contribute:
- Design and execute drug substance process development analytical activities including phase-appropriate method development, preliminary isolation/identification of process impurities, understanding reaction kinetics/mechanism, and data management.
- Collaborate with drug substance process chemistry, analytical development and engineering to design and execute experiments for process optimization, scale-up, and technology transfer activities.
- Execution of analytical testing's for small molecule pharmaceuticals, such as HPLC, LC-MS, GC, KF, NMR, and solid state characterizations (XRPD, DSC, TGA, DVS) when needed
- Identify critical in-process-control issues and develop appropriate IPC methods
- Provide analytical support and expertise to troubleshoot process-related issues and implement corrective actions.
- Method development support for innovation and technology team, including support for 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.
- Stay updated on emerging trends and advancements in analytical chemistry, and process optimization methodologies.
- Identify opportunities for continuous improvement in analytical techniques, processes, and systems.
- Technology advancement: work cross-functionally to ensure continued innovation for the PA team and SMPD.
- Platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results.
- Contribute to complex/multiple projects or functional areas through leading or influencing others.
- Influence and support initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
- Ensure a productive and development-rich environment.
- Define more complex/novel approaches and methodologies to solving complex technical challenges.
- Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.
- Understand project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders.
- Provide technical leadership to project teams within area of expertise.
- Contribute significantly and independently to project work which may include multiple projects within functional area.
- Review, interpreting and communicating data cross-functionally within CMC (Chemistry, Manufacturing & Controls) and project teams.
- Plan and implement resolutions to technical problems/issues.
- Independently design and execute experiments, and reports results.
- Responsible for integrating scientific/technical efforts around cross-functional issues.
Requirements
- Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 5+ years relevant industry experience
- Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 3+ years relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 0+ years relevant industry experience
- Working knowledge of modern analyses for small molecule pharmaceuticals, particularly HPLC, GC, LC-MS, and associated analytical software and data processing platforms, such as Empower / Openlab
- Good understanding of synthetic organic chemistry
- Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and workable solutions.
- Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
- Communication Skills -Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents.
- Organization – Exercises time management and prioritization skills and can successfully manage multiple tasks simultaneously.
- Knowledge Sharing: Ability to capture organizational knowledge; improve solutions, processes, and deliverables through information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
- Resource Management -Ability to manage one's time within individual, departmental, and corporate goals, and timelines; management of internal and external resources (vendors).
- External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events.
- Able to interpret results of complex experiments and integrate data produced by other disciplines.
- Able to work in lab setting.
- Proficiency with utilizing typical literature searching techniques to solve technical problems.
- May require 5-10% travel.
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.