Senior Scientist, Biologics Process Analytics & AQbD

BioLife Plasma

Lexington, Northern (MA, KY)

Hybrid

USD 137,000 - 215,000

Full time

13 days ago

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Job summary

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

The role emphasizes AQbD, automation integration, and cross-functional collaboration, with a strong focus on chromatographic and ELISA assays.

Qualifications

Ph.D., MSc, or BSc in analytical chemistry, chemistry, biochemistry, or related field with ~3/6/11 years of relevant industry experience.
Proven experience leading and managing programs in process analytical development functions.
Strong expertise in developing chromatographic (UHPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice/Lab Chip GXII) and/or ELISA type assays.
Experience in development, phase-appropriate validation, transfer and lifecycle management of analytical methods using AQbD principles.
Knowledge on ICH and other regulatory guidance on analytical method development and lifecycle management.
Strong communication skills (verbal, written, data presentation).
Experience with laboratory automation capabilities (liquid handlers, dispensers, SCARA robots, mobile robots).
Experience with laboratory information management systems (LIMS) and digital/AI tools.

Responsibilities

Lead in-process analytical method development and serve as primary contact for biologics process development teams.
Develop, optimize, transfer, and sustain high-throughput analytical methods for biologics using AQbD principles.
Support method bridging, transfer, and analytics continuation for biologics programs with cross-functional teams.
Assist in transfer, training, implementation, and lifecycle management of methods in development labs.
Collaborate with automation SMEs to validate and integrate automation platforms into methods.
Serve as a scientific resource and trainer for analytical and automation technologies.