Biotech Stability Manager

3 weeks ago


Reston, Virginia, United States Meet Full time

Meet's innovative client has engaged us on an exciting new search for a talented Stability Manager. You will be responsible for managing stability studies and data analysis of preclinical and clinical development projects. This role offers the opportunity to join a growing biotech organization with a robust pipeline to combat infectious diseases across the globe.

Key Responsibilities:

  • Manage stability studies on development and clinical projects at CROs/CDMOs/CTLs globally
  • Creating and managing stability databases using JMP, conducting complex data analysis, reporting to teams across functions
  • Manage systems across deviations, CAPAs, change controls for stability

Requirements:

  • MS or BS with 5-10 years of industry experience
  • Strong understanding of analytical chemistry and stability testing, preferably for biologics programs
  • Experienced with JMP software and various statistical programs for stability study management
  • Solid understanding of regulatory guidelines and submissions
  • Ability to work with CMOs globally

Contact:

Please reach out to Amit Uma at 628 336 2772 or amit@peoplewithchemistry.com to learn more. Correspondence will be confidential.


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