Senior Analytical Development Scientist

4 days ago

Waltham, Massachusetts, United States Alkermes Full time
Job Summary

The Associate Principal Scientist position within Analytical Development at Alkermes leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. This role collaborates with cross-functional teams on analytical method development, molecule characterization, testing, and analysis throughout various stages of drug development.

Key Responsibilities
  • Develop and implement analytical methods for pre-clinical and clinical stage development programs
  • Manage external partners for method development, validation, and analytical testing, including stability program design and execution
  • Design and support analytical method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects
  • Lead laboratory investigations to determine root cause and implement corrective actions as needed
  • Collaborate with various CMC functions and CMC leadership to develop analytical strategies and deliver on key objectives
  • Author and review drug substance and drug product analytical sections for regulatory submissions
  • Present to cross-functional teams and effectively communicate critical analytical issues and solutions
  • Stay current with emerging technologies and industry trends to support Analytical Development
Requirements
  • PhD (> 3 years) or MS (> 7 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
  • Subject matter expertise in analytical method development for various separation and spectroscopic techniques with particular hands-on experience in developing discriminating dissolution test methods
  • Experience in mechanistic and scientific investigations, stability-indicating method development, rapid shelf-life determinations based on ASAP prime software, cGMP stability studies, and creative stability problem solving
  • Experience in a GMP regulated analytical environment preferred
  • Good understanding of the role of Analytical Development within the drug development process
  • Solid leadership skills and interpersonal skills and excellent verbal and written communication skills
  • Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
  • Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain project timelines

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