Process Analytics Scientist – In-Process Method Development

Takeda; Cambridge (MA); On-site; USD 104,000 - 163,000; Full time

Job summary

Takeda in Cambridge, MA is seeking an Associate Analytical Development Scientist to design and qualify high-throughput methods for in-process testing of synthetic molecules using HPLC/UPLC, GC/GC-MS, FT-IR/NMR, and Karl Fischer.

You will independently plan experiments, analyze data, and report results to support process development, comparability, and regulatory submissions, while partnering with Quality, Compliance, Stability, and Manufacturing teams.

Qualifications

• Typically associate degree with 7+ years, bachelor’s degree with 5+ years, or master’s degree with 3+ years of relevant industry experience in analytical development for synthetic molecules.
• Previous hands-on experience working in a laboratory setting is required.
• Strong expertise and practical knowledge of analytical techniques such as HPLC/UPLC, GC/GC-MS, FT-IR/NMR, Karl Fischer, and particulate matter testing.
• Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions to technical and cross-functional stakeholders.
• Ability to prepare and review technical documentation including protocols, reports, data summaries, method documents, SOPs, and tech transfer materials.
• Demonstrated problem-solving skills, troubleshooting, and risk interpretation.
• Ability to work across departments with regard to timelines, deliverables, and data quality.
• Understanding of data integrity, ELN/LIMS documentation, safety, and good documentation practices.
• Ability to manage multiple priorities while maintaining scientific quality and timelines.
• Clear written and verbal communication of technical information to stakeholders.
• Working understanding of AQbD principles & ICH guidelines; experience with automation and AI tools is highly desirable.

Responsibilities

• Independently design, develop, qualify and report fit-for-purpose analytical methods for in-process testing of synthetic molecules.
• Collaborate with in-process testing teams for seamless method transfer and life-cycle management.
• Apply AQbD principles and collaborate with QA, Compliance, Stability to support transfer activities and tool integration.

Skills

HPLC/UPLC

GC/GC-MS

FT-IR/NMR

Karl Fischer

AQbD

ICH guidelines

Laboratory automation

ELN/LIMS

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree

Master’s degree

Associate degree

Tools

LIMS

Automation platforms

AI tools

SCARA robots

Job description

Takeda in Cambridge, MA is seeking an Associate Analytical Development Scientist to design and qualify high-throughput methods for in-process testing of synthetic molecules using HPLC/UPLC, GC/GC-MS, FT-IR/NMR, and Karl Fischer.

You will independently plan experiments, analyze data, and report results to support process development, comparability, and regulatory submissions, while partnering with Quality, Compliance, Stability, and Manufacturing teams.