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Associate Director, Antisense Oligonucleotide Analytical Development

Biogen

Biogen seeks an Associate Director to lead analytical development for antisense oligonucleotide drug substances and products. The role combines scientific and people leadership, overseeing method development, control strategies, regulatory submissions, and team management within a matrixed CMC environment.

Responsibilities

  • Lead day-to-day analytical development for ASO drug substance and product programs aligned with portfolio priorities
  • Develop and implement phase-appropriate analytical methods, control strategies, and specifications for ASO materials
  • Provide technical leadership on method development, validation, transfer, and lifecycle management activities
  • Author and review analytical content for regulatory submissions, reports, and health authority responses
  • Manage, mentor, and develop analytical team members while fostering innovation and cross-functional collaboration

Requirements

  • Ph.D. in analytical chemistry, pharmaceutical sciences, or related discipline with 6+ years relevant experience; or M.S. with 8+ years; or B.S. with 10+ years
  • Demonstrated ASO analytical development experience including method development, validation, stability, and specification setting
  • Working knowledge of regulatory expectations, ICH guidance, and GMP principles for CMC submissions
  • Experience leading analytical workstreams and cross-functional teams in matrixed environments
  • Scientific staff management and mentoring experience
  • Strong written and verbal communication of complex scientific information
Vacancy posted more than 2 months ago

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