Head of Analytical Controls

4 days ago


Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time
Job Summary

We are seeking a highly experienced and skilled professional to lead our Analytical Controls team as Head of Analytical Controls. This role will be responsible for overseeing the global CMC program, managing a team of managers and scientists, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead and develop a global team of managers and scientists in the field of analytical controls and compliance
  • Oversee the global CMC program, including management and oversight of all project-related analytical control topics, development requirements, and program milestones
  • 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
  • Contribute to overall functional direction globally and represent the 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 or Advanced degree with 15+ years of relevant industry experience
  • Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's
  • Demonstrates effective project management skills, GMP and compliance experience, and analytical method development experience
  • Regulatory submission experience required with basic knowledge for regulatory guidelines
  • Global cultural awareness, manage inclusively, and familiarity with working in a global setting
  • Excellent command of English (all sites)
  • People managerial experience preferred, team player with flexible personality, and highly reliable, self-motivated, responsible, and curious personality open to learn and develop
What We Offer

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.

Location

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



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