Senior Scientist – Analytical Development Biologics Early Stage

1 day ago

Lexington, Kentucky, United States Takeda Pharmaceutical Full time
About the Role

Takeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Scientist – Analytical Development Biologics Early Stage, you will lead efforts in the development of scientific methods, implement evolving scientific technology, and influence strategic planning within AD and across Pharmaceutical Sciences to deliver on program strategy and initiatives.

You will demonstrate expertise in multiple areas of analytical technologies, in-depth working knowledge of biologics CMC development, and other Pharmaceutical Science functional roles. As part of the Analytical Development team, you will report to the Product Attribute Science US Early Stage Lead.

Key Responsibilities
  • Design and execute early phase biologics development by applying knowledge of research to development workflows.
  • Recognized as an SME within function, mentoring and training junior employees across multiple technologies involved in biologics development.
  • 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.
  • Prepare documentation for regulatory filings, authors technical reports, may author publications, and demonstrate involvement with wider professional/scientific community.
Requirements
  • 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.
About Takeda

Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are a certified Global Top Employer, offering stimulating careers, encouraging innovation, and striving 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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