Senior Manager of Analytical Controls

4 days ago

MA United States Takeda Pharmaceutical Full time
Job Summary

We are seeking a highly experienced and skilled professional to lead our global team of managers and scientists in the field of analytical controls and compliance. As the Senior Manager of Analytical Controls, you will be responsible for overseeing the global CMC program, managing and overseeing all project-related analytical control topics, development requirements, and program milestones, including global reporting.

Key Responsibilities
  • Lead and develop a global team of managers and scientists and their teams in the field of analytical controls and compliance
  • Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements, and program milestones including global reporting
  • Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems
  • Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process, and product knowledge. Including the support of transfer of development assets from Research, main ownership starting at start of GMP activities until hand-over to the commercial organization.
  • Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science and across the global Takeda organization.
  • Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities.
Requirements
  • Bachelor degree with 20+ years of experience
  • Advanced degree with 15+ years relevant industry experience
  • Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMPs
  • Demonstrates effective project management skills
  • GMP and compliance experience required
  • Analytical method development experience required
  • Regulatory submission experience required with basic knowledge for regulatory guidelines
  • Global cultural awareness, manage inclusively
  • Familiarity with working in a global setting
  • Excellent command of English (all sites).
  • People managerial experience preferred
  • Team player with flexible personality but able to be persistent and assertive
  • Highly reliable, self-motivated, responsible, and curious personality open to learn and develop and a pronounced desire for improvement
About Takeda

Takeda is proud in its commitment of 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.

Location

Cambridge, MA

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