Associate Director, Analytical Development, Bioanalytics Late Stage

3 weeks ago


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

Job Summary:

We are seeking a highly skilled and experienced Associate Director to lead our Analytical Development and Bioanalytics team. The successful candidate will be responsible for developing and implementing scientific methods and technology, driving team objectives, and managing team performance.

Key Responsibilities:

  • Independently conduct technical analyses and risk assessments to build knowledge of processes and methods.
  • 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.

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, and any other characteristic protected by law.

Location:

Lexington, MA

Benefits:

We offer a competitive salary range of $149,300.00 to $234,300.00, depending on qualifications and experience. Additionally, we offer a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, 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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