Associate Director, Analytical Development, Bioanalytics Late Stage

1 week ago


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

We are seeking an experienced Associate Director to lead our Analytical Development team in Bioanalytics Late Stage. The successful candidate will have a strong background in analytical development, with expertise in scientific methods and technology implementation. They will be responsible for driving team objectives, managing team performance, and developing strategic plans to deliver on program strategy and initiatives.

Key Responsibilities
  • Conduct technical analyses and risk assessments to inform related strategies across program and potentially across Pharmaceutical Sciences.
  • Manage staff with accountability for performance and talent development.
  • Work with senior management to develop and set vision for departmental activities and management of resources.
  • Establish and manage operational processes within the department and influence scientific and process improvement in global AD.
  • Review and approve analytical-related CMC sections of BLA/MAA regulatory submissions.
  • Represent AD and provide guidance to PST teams by leveraging cross-program learning.
  • Review and interpret complex data, industry trends, and incorporate into strategy to communicate clearly to PS functional leadership and partner functional leadership as appropriate.
  • Drive vendors and sourcing/consultancy strategy both internally and externally.
  • Develop AD skill set to enable department vision and management of team performance.
Requirements
  • Bachelor's degree with 15+ years of relevant experience, Master's degree with 13+ years of relevant experience, or Ph.D. with 7+ years of relevant experience.
  • Provides technical/managerial leadership for analytical function, in-depth understanding of PS deliverables and program timelines, driving program strategy, and demonstrating leadership in functional and cross-functional teams.
About Takeda

Takeda is committed 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.

Location

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full-time



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