Biologics In-Process Analytics Lead (AQbD)

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

Job summary

Takeda seeks a Senior Scientist, Biologics Process Analytical Method Development to lead in-process analytical method development for biologics programs in Lexington, MA. You will collaborate with Biologics Process Development, Analytical Development, Quality and Stability teams to develop high-throughput methods and support process decisions.

You will apply AQbD principles, validate and transfer methods, and help automate laboratory workflows.

Qualifications

• Ph.D. in analytical chemistry, chemistry, biochemistry, or related field with minimum industry experience.
• Experience leading programs in process analytical development and transfer.
• Strong expertise in chromatographic (U/HPLC), electrophoretic and isoelectric focusing assays or ELISA.

Responsibilities

• Lead in-process analytical method development and serve as main contact for biologics process development teams.
• Develop, transfer and sustain high-throughput analytical methods using AQbD principles.
• Collaborate with Analytical Development, Quality, Compliance and Stability teams for method transfer and lifecycle management.
• Validate and integrate laboratory automation platforms into process analytical methods.

Job description

Takeda seeks a Senior Scientist, Biologics Process Analytical Method Development to lead in-process analytical method development for biologics programs in Lexington, MA. You will collaborate with Biologics Process Development, Analytical Development, Quality and Stability teams to develop high-throughput methods and support process decisions.

You will apply AQbD principles, validate and transfer methods, and help automate laboratory workflows.