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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 Biologics Early Stage (AD) where you will independently lead efforts in the development of scientific methods, the implementation of evolving scientific technology, and influence strategic planning within AD and across Pharmaceutical Sciences to deliver on program strategy and initiatives. You will also demonstrate expertise in multiple areas of analytical technologies, in-depth working knowledge of biologics CMC development, and other Pharmaceutical Science functional roles, and other organizational partners' (e.g. Research, GMSGQ) roles. As part of the Analytical Development, you will report to Product Attribute Science US Early Stage Lead.

How you will contribute:

• Design and execute early phase biologics development by applying knowledge of research to development workflows (e.g., developability).

• Recognized as an SME within function, mentoring and training junior employees across multiple technologies involved in biologics development such as icIEF, SEC, CE-SDS, glycan analysis and influencing technical improvement.

• Independently design and execute experimental plans and define more complex or novel resolutions to technical challenges within the program and broader department.

• Responsible for sole technical leadership and strategic planning within own program(s) and wider AD through mentorship or influencing of others to meet cross functional program goals.

• Represent AD within PS teams demonstrating ability to understand and communicate impact of technical risks on CMC program timelines.

• Review and interpret complex data, communicating clearly to AD functional leadership and cross functional leadership as appropriate.

• Proactively build relationships with key vendors and partners both internally and externally.

• Help with operational improvement of AD, supporting and influencing ongoing initiatives (e.g. in silico CMC, lab automation).

• Prepare documentation for regulatory filings (IND/IMPDs), authors technical reports, may author publications and demonstrate involvement with wider professional/scientific community.

Minimum Requirements/Qualifications:

• Bachelors degree with 11+ yrs relevant experience, Masters degree with 9+ yrs relevant experience, Ph.D. with 3 yrs relevant experience.

• Competent in multiple analytical techniques with SME knowledge in multiple specific analytical techniques relevant to analytical function, fully understands wider PS deliverables and program timelines, competent at defining program strategy, ability to lead functional and cross functional teams.

• Able to communicate complex data clearly to cross functional teams and leadership, able to influence cross functional teams and ways of working, good scientific writing skills, able to work highly independently.

• Knowledge of analytical related guidance/practice (e.g., ICH, WHO, USP, cGXP) in biologics development.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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