Head of Analytical Development Biologics

vor 2 Monaten

Wien, Wien, Österreich Takeda Vollzeit

Job Summary

Takeda is seeking a highly experienced and skilled professional to lead our analytical development team for late stage biologics. As the Head of Analytical Development Biologics - Late Stage, you will be responsible for overseeing the development of analytical methods and strategies for our biologics portfolio, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities

  • Lead and develop a team of managers and scientists in analytical development for late stage biologics
  • Oversee and manage phase-appropriate analytical development for clinical trial material efforts across three main areas: characterization and comparability, method development for non-routine and release/stability use, and method development for In-Process analytics
  • Contribute to product development from Pharmaceutical Sciences to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization
  • Represent the function within CMC/Pharmaceutical Science and across the global Takeda organization
  • Implement and execute externalization activities with external partners

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
  • Direct experience in analytical development for biologics, especially late stage assets
  • Knowledge and experience with product development and clinical supply processes and product commercialization
  • Experience in reviewing and approving analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions

What We Offer

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance

Location

Boston, MA

U.S. Base Salary Range

$205,000 - $322,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Takeda is an equal opportunity employer and welcomes applications from diverse candidates.

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