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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Scientist – Analytical Development (AD) Synthetic Molecules – Early Development  where you will provide and drive theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area to drive efficient progress to early regulatory agency filings. You will also leverage analytical technical skill(s) as a resource/expert within Analytical Development, and be responsible for significant or sole technical leadership within project or complex studies. As part of the Analytical Development team, you will report to Director, Analytical Development.

How you will contribute:

• Develops project and technical strategy within area of expertise.

• Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC functions and other development functions.

• Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review.

• Coordinate transfer of projects as necessary within Takeda or externally.

• Identify and plan broader technical objectives (project and scientific related) with input from manager as needed.

• Identify and recommend vendors as appropriate.

• Coordinate cross-functional teams and resolutions, with a focus on scientific /technical challenges.

• Contribute to complex/multiple projects or functional areas through leading or influencing others.

• Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.

• Review, interpret, and communicate data cross functionally within CMC and project teams.

• Coordinate others in creating technical reports including reviewing and editing.

• Conduct analysis of technical and conceptual risk and trends

• Identify process trends and define process strategy or use of novel technologies.

• Recognized as a technical expert and resource within function.

• Significant technical responsibility for a project area/technical program within the department and potentially across CMC (e.g. CMC team AD representative or team lead).

• Represent functional area on CMC project teams by communicating activities from designated functional area to project team.

• Integrate scientific/technical efforts around cross-functional issues.

• Identify topics for initiatives and lead local/global initiatives as directed by senior staff.

• Ensure a productive and development-rich environment; Serves as a technical resource or mentor for junior staff and uses expertise in laboratory technology as a functional resource/trainer.

• Define more complex/novel approaches and methodologies to solving complex technical challenges.

• Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.

• Manages key vendor relationships across multiple projects as appropriate, and affects resol