Senior Biologics Process Analytics Lead, AQbD & Automation

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Scientist, Biologics Process Analytical Method Development in Lexington, MA. You will lead in-process analytical method development for biologics programs, partnering with Process Development, Analytical Development, Quality and Stability to develop high-throughput methods and support transfer and lifecycle management.

You will apply AQbD principles, integrate automation where appropriate, and serve as a scientific resource on analytical methods and automation

Qualifications

• PhD/MSc/BS in analytical chemistry, chemistry or biochemistry with relevant industry experience.
• Experience leading and managing programs in process analytical development.
• Strong expertise in developing chromatographic (UHPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GXII®) and/or ELISA type assays.
• Experience in development, validation, transfer and lifecycle management of analytical methods using AQbD principles.
• Knowledge of ICH and regulatory guidance on analytical method development and lifecycle management.
• Must have effective communication skills, including verbal, written, and data presentation.
• Experience with laboratory automation capabilities and digital/AI tools is desirable.

Responsibilities

• Lead in-process analytical method development and serve as the main contact for biologics process development teams.
• Develop, optimize, transfer, and sustain high-throughput analytical methods for biologics using AQbD.
• Partner with Analytical Development, Quality, Compliance, and Stability to support method bridging and transfer.
• Support transfer, training, implementation, and lifecycle management of methods.
• Collaborate with automation experts to validate and integrate automation platforms into methods.
• Act as scientific resource and trainer for analytical and automation technologies.
• Evaluate new tools, platforms, and vendor solutions for lab automation as needed.

Skills

Program management

Analytical method development

AQbD principles

Communication

Education

PhD in analytical chemistry

MSc in chemistry

BSc in biochemistry

Tools

Liquid handlers

Dispensers

SCARA robots

Mobile robots

LIMS

AI tools

Job description

Takeda is seeking a Senior Scientist, Biologics Process Analytical Method Development in Lexington, MA. You will lead in-process analytical method development for biologics programs, partnering with Process Development, Analytical Development, Quality and Stability to develop high-throughput methods and support transfer and lifecycle management.

You will apply AQbD principles, integrate automation where appropriate, and serve as a scientific resource on analytical methods and automation