Associate Director, Analytical Development, Bioanalytics Late Stage

3 weeks ago

Lexington, Kentucky, United States BioSpace, Inc. Full time
Job Summary

As an Associate Director in Analytical Development, you will lead efforts in developing scientific methods and technology, implementing evolving scientific technology, driving team objectives, and managing team performance in line with Pharmaceutical Sciences' strategy to deliver on program strategy and initiatives. You will have acquired expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of Pharmaceutical Sciences and other partner organizational roles and program strategy.

Key Responsibilities
  • Conduct technical analyses and risk assessments to build knowledge of processes, methods, and inform related strategies across program and potentially across Pharmaceutical Sciences, especially for Bioanalytics for late stage Biologics programs.
  • 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.
  • Own Bioanalytics late stage area, responsible for establishing and managing operational processes within the department and influencing scientific and process improvement in global AD.
  • Have strong knowledge of ICH and other regulatory guidelines, including Analytical Quality by Design (AQbD).
  • Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese, and US CMC regulatory requirements for Biologics.
  • Represent AD and provide guidance to PST teams by leveraging cross-program learning, demonstrating ability to understand and communicate impact of technical and project risks on program timelines and other PS functions.
  • 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.
  • Responsible for developing AD skill set to enable department vision, and management of team performance, engaging with external professional/scientific community, may drive publication strategy.
  • Complete all required training appropriate to role and function in a timely manner.
Requirements
  • Bachelor's degree with 15+ years of relevant experience, Master's degree with 13+ years of relevant experience, 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, demonstrating leadership in functional and cross-functional teams.
  • Able to communicate to cross-functional senior leadership on technology implementation strategy, able to lead or contribute in cross-functional teams and ways of working, provide guidance around project leadership and strategy to team members as well as technical guidance.
Equal Employment Opportunity

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

Lexington, MA

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