Process Analytics Scientist: Synthetic Molecule Development

Takeda Pharmaceutical Co.

Cambridge (MA)

On-site

USD 116,000 - 182,000

Full time

4 days ago

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Job summary

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Scientist, Process Analytics within the Synthetic Molecule Process Development group.

You will support process analytics for drug substance development, including method development, impurity identification, reaction kinetics understanding, and data management. You will lead analytical testing using HPLC, LC-MS, GC, KF, NMR, and solid-state techniques, collaborate cross-functionally for optimization and tech transfer, and contribute to

Qualifications

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.

Responsibilities

Design and execute drug substance process analytics 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.