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Senior Principal Scientist

2 months ago


Cambridge, Massachusetts, United States Novartis Group Companies Full time
Job Summary

As a Senior Principal Scientist in the Translational Medicine Drug Disposition Bioanalytical group at Novartis Group Companies, you will have the opportunity to make a significant impact in the development of novel modality biologics. This vital leadership role requires a collaborative nature, a commitment to teamwork, and a relentless focus on improving patient care.

Key Responsibilities
  • Oversee the development, validation, and sample analysis for mass spectrometry assays for pharmacokinetic and immunogenicity bioanalysis for all therapeutic modalities.
  • Manage clinical study timelines and ensure accuracy of project progress through company tracking tools.
  • Contribute to the strategic and operational aspects of the team and propose/implement modifications and improvements, both operationally and technologically, with a focus on continuous quality and efficiency improvements.
  • Contribute and review relevant bioanalytical sections to regulatory and submission documents.
  • Represent the Bioanalytical group in various advisory councils and stakeholder meetings.
  • Hire and lead a team of up to 5 scientists carrying out bioanalytical development/validation and regulated sample analysis.
Requirements
  • M.S. with 10+ years GCP experience in a pharmaceutical, CRO, or related industry.
  • Demonstrated success building, leading, and developing a scientific team.
  • Hands-on experience with the development of mass spectrometry assays with the proven ability to develop BA strategies across a variety of modalities using different technologies, including biologics.
  • Strong engagement, interpersonal communication skills, and ability to work in a dynamic matrix environment with frequently shifting priorities and timelines.
  • A thorough understanding of industry landscape and Health Authority guidelines.
  • Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents.
Preferred Qualifications
  • PhD
About Novartis Group Companies

Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to becoming the most valued and trusted medicines company in the world. We believe that our associates are the driving force behind our success, and we strive to create an inclusive and diverse environment that fosters growth and development.