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Head of Analytical Controls

2 months 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 development and implementation of analytical methods and controls for our pharmaceutical products.

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 for Pharmaceutical Sciences, 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: GMP review and control for analytical documents, Release testing oversight, Stability and Shelf life, Reference Standard Management, and 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, facilitate development of execution plans for each, and ensure completion of agreed-upon activities.
Accountabilities
  • Responsibility for people and group management.
  • Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment.
  • Build future leadership while mentoring direct reports and junior employees.
  • Lead and implement wider cross-functional/cross-divisional strategy and decisions and drive initiatives to completion.
  • Develop and manage strategies for regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads.
  • Lead global CMC and Quality key initiatives and represent Pharm Sci to other cross-functional stakeholder key initiatives.
  • Analyze and synthesize concepts from diverse information – and articulate.
  • Develop and set vision and direction of departmental activities and infrastructure with specific focus but not limited to compliance, quality, systems, and processes for AD and PS.
  • In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations.
  • Harmonization and standardization of AD but also PS processes, reporting, systems, and documents in collaboration with Quality. Establishes and manages operational processes within the department/function.
  • Benchmark current trends within industry for all areas within Analytical Controls also including strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders e.g. GMS/GQ for company-wide systems, IT and PSST for new solutions.
  • Look for external benchmarks that help to aid superior performance of products, processes, and people.
  • Manage complete line function responsibility for all departmental programs and initiatives.
  • Directs, informs, and applies outsourcing strategy for department in conjunction with senior staff and global line and function heads.
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 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 (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.