Senior Scientist, Biologics Process Analytical Method Development

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About the role:
The Senior Scientist Biologics Process Analytical Method Development is responsible for leading in-process analytical method development for biologics this role you will partner with Biologics Process Development Analytical Development Quality and Stability teams to develop transfer and sustain high-throughput analytical methods that support process and product development. You will apply phase-appropriate approaches and Analytical Quality by Design principles integrate automation where appropriate and provide clear scientific input that supports process development decisions.

How you will contribute:

• Lead in-process analytical method development needs and serve as the main contact for biologics process development and in-process testing teams.
• Develop optimize transfer and sustain high-throughput fit-for-purpose analytical methods for biologics development using phase-appropriate approaches and Analytical Quality by Design (AQbD) principles.
• Partner with Analytical Development Quality Compliance and Stability teams to support method bridging transfer and an analytical results continuum for biologics programs.
• Support the transfer training implementation and lifecycle management of methods in process development laboratories including documentation and troubleshooting plans.
• Work with automation subject matter experts to validate and integrate laboratory automation platforms into process analytical methods.
• Serve as a scientific resource and trainer for analytical and automation technologies including support for new team members and interns.
• Evaluate new tools platforms and vendor solutions for laboratory automation and analytics as needed.

What you bring to Takeda:

• Ph.D. MSc. or analytical chemistry chemistry biochemistry or related field with typical of 3 years (Ph.D.) 6 years (MS) or 11 years (BS) of relevant industry experience.
• Proven experience leading and managing programs preferably in process analytical development functions.
• Strong expertise in developing chromatographic (U/HPLC) electrophoretic and isoelectric focusing (CE-SDS/Maurice/Lab Chip GXII) and/or ELISA type assays.
• Experience in development phase-appropriate validation transfer and life cycle management of analytical methods using AQbD principles.
• Knowledge on ICH and other regulatory guidance on analytical method development and life cycle management.
• Must have effective communication skills including verbal written and scientific data presentation.
• 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.

Takeda Compensation and Benefits Summary

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For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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