Senior Scientist, Biologics Process Analytics & AQbD

Takeda; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda in Lexington, MA is seeking a Senior Scientist, Biologics Process Analytical Method Development to lead in-process analytical method development for biologics programs and to collaborate with Biologics Process Development, Analytical Development, Quality, and Stability teams to transfer and sustain high-throughput methods.

The role emphasizes phase-appropriate approaches, AQbD, automation integration, and providing scientific input to guide process development decisions.

Qualifications

• PhD, MSc, or BSc in analytical chemistry, chemistry, biochemistry, or related field with industry experience.
• Experience leading and managing programs in process analytical development.
• Strong expertise in chromatographic, electrophoretic, and ELISA assays.
• Experience with AQbD-based development and lifecycle management.
• Knowledge of ICH and regulatory guidance for analytical methods.
• Excellent verbal, written, and data presentation skills.

Responsibilities

• Lead in-process analytical method development and act as main contact for PD and testing teams.
• Develop and transfer high-throughput, fit-for-purpose analytical methods for biologics.
• Partner with Analytical Development, Quality, Compliance, and Stability teams for method transfer.
• Support transfer, training, implementation, and lifecycle management of methods.
• Collaborate with automation experts to integrate lab automation into methods.
• Provide scientific mentorship and support for new team members and interns.

Skills

Analytical method development

AQbD principles

Chromatography (HPLC/UHPLC)

ELISA assays

Communication skills

Laboratory automation

LIMS / AI tools

Cross-functional collaboration

Education

PhD in analytical chemistry / related field

MSc in analytical chemistry / related field

BSc in analytical chemistry / related field

Tools

HPLC/UHPLC

Maurice Lab Chip GXII

ELISA platforms

Laboratory automation hardware

Job description

Takeda in Lexington, MA is seeking a Senior Scientist, Biologics Process Analytical Method Development to lead in-process analytical method development for biologics programs and to collaborate with Biologics Process Development, Analytical Development, Quality, and Stability teams to transfer and sustain high-throughput methods.

The role emphasizes phase-appropriate approaches, AQbD, automation integration, and providing scientific input to guide process development decisions.