Associate Director, Analytical Development, Bioanalytics Late Stage

1 week ago


Lexington, Kentucky, United States BioSpace, Inc. 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 benchmarking industry trends and regulatory guidelines.

Key Responsibilities
  • Lead the development of scientific methods and technology in analytical development
  • Drive team objectives and manage team performance in line with Pharmaceutical Sciences' strategy
  • 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
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
  • 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
What We Offer

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.

We offer a competitive salary range of $149,000 to $234,300, as well as a comprehensive benefits package, including 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.



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