Senior Director, Pharmaceutical Science

4 weeks ago


Cambridge, Massachusetts, United States Takeda Full time

Job Description

This is a senior leadership role within the Pharmaceutical Science organization at Takeda. The Senior Director will be responsible for leading and developing a global team of managers and scientists in the field of analytical controls and compliance.

Key Responsibilities:

  • Lead and manage a global team of managers and scientists in analytical controls and compliance.
  • Oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global reporting.
  • Manage core tasks for Analytical controls for clinical trial material efforts across four main areas: GMP review and control for analytical documents; Release testing oversight, Stability and Shelf life; Reference Standard Management; 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.
  • Represent the function within CMC/Pharmaceutical Science and across the global Takeda organization.
  • Implement and execute externalization activities with external partners.

Requirements:

  • Bachelor degree with 20+ years of experience or 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 cGMP's.
  • 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.
  • People managerial experience preferred.

Compensation and Benefits:

The estimated salary range for this position is $205,100.00 - $322,300.00 per year. U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.

About Us:

Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants 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.



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