Associate Scientist, Process Analytical Method Development

Takeda•Cambridge, MA

27d•$103,500 - $162,690•Onsite

About The Position

This role is within the Analytical Development organization, reporting to the Associate Director, Process Analytics Lead. The Associate Scientist will focus on in-process method development for synthetic molecules (Small molecules, Oligonucleotides, Peptides) utilizing various analytical techniques including liquid chromatography, gas chromatography, spectroscopy, Karl Fischer, and particulate matter testing. The position involves independently planning, executing, analyzing, and reporting method development experiments to support critical aspects of product lifecycle, such as product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. Collaboration with departmental and cross-functional partners is essential for generating high-quality data, resolving technical challenges, and communicating results that inform decision-making for synthetic molecule programs. This role does not involve direct people management.

Requirements

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 liquid chromatography (HPLC/UPLC), gas chromatography (GC/GC-MS), spectroscopy (FT-IR, NMR), 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, including the ability to troubleshoot technical issues, propose practical solutions, and escalate risks appropriately.
Ability to work across departmental and cross-functional teams with an understanding of project timelines, deliverables, and data quality expectations.
Understanding of data integrity principles, ELN/LIMS documentation, laboratory safety, and good documentation practices.
Ability to manage multiple priorities with general direction while maintaining attention to scientific quality, timelines, and documentation standards.
Ability to communicate technical information clearly in writing and in conversation, and to present technical information clearly to scientific and project stakeholders.
Working understanding of AQbD principles & ICH guidelines.

Nice To Haves

Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable.
Experience with laboratory information management systems and other digital or AI tools is desirable.

Responsibilities

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 within synthetic molecule process development organization for seamless method transfer and life cycle management.
Apply Analytical Quality by Design (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 and platforms into process analytical methods.
Evaluate new tools, platforms, and vendor solutions for in-process analytics as needed.