In-Process Analytics Scientist – Method Development

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); In loco; USD 104.000 - 163.000; Tempo pieno

Descrizione del lavoro

Takeda, Cambridge, MA, is seeking a detail‑oriented analyst to lead in‑process method development for synthetic molecules. You will design, qualify and transfer high‑throughput analytical methods, collaborating across Analytical Development, Quality and Stability teams to ensure data integrity and regulatory readiness.

The role emphasizes independent planning, data analysis, and clear documentation, with exposure to automation, PAT and digital tools. A strong laboratory background is essential.

Competenze

• 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 one or more relevant analytical techniques for testing synthetic molecules during process development such as HPLC/UPLC, GC/GC-MS, spectroscopy, Karl Fischer, and particulate matter testing, or related techniques.
• 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 technology transfer materials.
• Demonstrated problem-solving skills and ability to troubleshoot issues, escalate when needed, and maintain data quality.
• Ability to work across departmental and cross-functional teams with project timelines and data quality expectations.
• Understanding of data integrity, ELN/LIMS documentation, laboratory safety and good documentation practices.
• Ability to manage multiple priorities with scientific quality and timely documentation.
• Ability to communicate technical information clearly in writing and conversation; present to scientific and project stakeholders.
• Working understanding of AQbD principles and ICH guidelines.
• Experience with laboratory automation capabilities and digital tools is desirable.

Mansioni

• Independently design, develop, qualify and report fit-for-purpose, scientifically sound and high-throughput analytical methods for in-process testing of synthetic molecules under general direction.
• Work closely with in-process analytical testing team for seamless method transfer and lifecycle management.
• Apply AQbD principles and phase-appropriate approaches for method development.
• Partner with Analytical Development, Quality, Compliance, and Stability teams to support method bridging and transfer activities.
• Work with automation, digital and PAT subject matter experts to validate and integrate technologies into process analytical methods.
• Evaluate new tools, platforms, and vendor solutions for in-process analytics as needed.

Conoscenze

Analytical method development

HPLC/UPLC

GC/GC-MS

Spectroscopy

Karl Fischer

AQbD principles

ICH guidelines

Data analysis

Technical documentation

Laboratory automation

Cross-functional collaboration

Formazione

Associate degree

Bachelor’s degree

Master’s degree

Strumenti

Liquid handlers

Dispensers

SCARA robots

Mobile robots

LIMS

Digital/AI tools

Descrizione del lavoro

Takeda, Cambridge, MA, is seeking a detail‑oriented analyst to lead in‑process method development for synthetic molecules. You will design, qualify and transfer high‑throughput analytical methods, collaborating across Analytical Development, Quality and Stability teams to ensure data integrity and regulatory readiness.

The role emphasizes independent planning, data analysis, and clear documentation, with exposure to automation, PAT and digital tools. A strong laboratory background is essential.