Associate Scientist, Process Analytical Method Development

3316 Takeda Development Center Americas•Cambridge, MA

26d•Onsite

About The Position

You will report to the Associate Director, Process Analytics Lead within Analytical Development organization. You will contribute to in-process method development activities for synthetic molecules (Small molecules, Oligonucleotides, Peptides) using liquid chromatography, gas chromatography, spectroscopy, Karl Fischer, and particulate matter testing. You will independently plan, execute, analyze, and report method development experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision-making for synthetic molecule programs. This role does not include 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.