Daiichi Sankyo

posted 21 days ago

Full-time - Senior
10,001+ employees
Health and Personal Care Retailers

About the position

The job holder is responsible for leading CMC (Chemistry, Manufacturing, and Controls) projects in the ADC/Bio#2 area at Daiichi Sankyo. This role involves developing and proposing integrated CMC product strategies, managing project teams, and ensuring alignment with research and development units. The position requires overseeing project budgets and activity plans while leading cross-functional product decisions and acting as a liaison with strategic partners.

Responsibilities

  • Develop and propose integrated CMC product level strategy based on a cross-functionally designed strategy.
  • Develop activity plans and budgets for projects in alignment with unit strategy and CDP.
  • Lead cross-functional product decisions including tech development and manufacturing network strategy.
  • Manage project teams by working with other L-1 functions to assign appropriate talent and delegate tasks.
  • Interface with R&D as the CMC working group leader of GPT to ensure alignment across units.
  • Participate in CMC/SC-related decision-making meetings with strategic alliance partners.

Requirements

  • Bachelor's Degree in chemistry, biochemistry, pharmaceutics, or related discipline required; PhD preferred.
  • 10+ years of professional experience in the pharmaceutical/biopharmaceutical industry.
  • At least 2+ years in a direct or matrix management position in a CMC-related function.
  • 10+ years of expertise in project management, process, product, and/or analytical development activities.
  • Extensive knowledge of global CMC regulatory requirements and NDA or BLA submission experience for ADC/Bio.

Nice-to-haves

  • Expertise in oncology strongly preferred.
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