Head of Analytical Development

5 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Job Description

This role offers the opportunity to lead a global team of managers and scientists in the field of analytical development for late stage synthetic molecules. The successful candidate will oversee and manage analytical development efforts across three main areas: characterization and in vitro comparability, method development and validation for release/stability use, and method development for In-Process analytics.

The ideal candidate will contribute to product development and transfer from development to commercialization by collaborating with multiple functions within the Pharmaceutical Science organization. They will also contribute to overall functional direction globally and represent the function within CMC/Pharmaceutical Science and across the global Takeda organization.

Key Responsibilities:

  • Direct and indirect supervisory responsibilities in analytical areas for development of high-quality late stage synthetic molecules therapeutics
  • Drive global late stage team to obtain scientific data; data compilation and review; preparation and review of technical reports, global regulatory filings, and other documentation
  • Collaborate with other functions in Pharmaceutical Sciences to encourage strategic alignment and successful achievement of shared goals

Requirements:

  • Master or PhD in chemistry, biology, pharmacy, or related pharmaceutical science; at least 10 years relevant industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple analytical development areas
  • Leadership experience of teams including managers and scientists. Development of team members to managers of scientific analytical teams including individual contributors with an exceptional commitment to science
  • Direct experience in analytical development for synthetic molecules, especially late stage assets, and ability to drive study completion in a timely, sustainable, robust and cost-efficient manner


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