CMC Quality By Design Expert

vor 1 Tag


Bern, Bern, Schweiz Consultys Vollzeit

Job Title: CMC Quality By Design Expert

About Us: At Consultys, we are a leading consulting firm dedicated to helping pharmaceutical and biotechnology companies navigate the complex world of Quality by Design (QbD) and regulatory affairs.

About the Role:

We are seeking an experienced Quality by Design Consultant who can lead our client's CMC (Chemistry, Manufacturing, and Controls) projects. As a key member of our team, you will be responsible for providing strategic guidance on QbD process development, scale-up, technology transfer, process validation, and CMC regulatory affairs.

Your Key Responsibilities:

  • Lead small expert teams to compile high-quality CMC information and regulatory dossiers
  • Develop and implement QbD processes to ensure compliance with regulatory requirements
  • Collaborate with cross-functional teams to drive business outcomes and improve project efficiency
  • Provide support for internal department improvement initiatives and strategy/innovation projects

Requirements:

  • 5+ years' experience in the pharmaceutical industry or other high-tech areas
  • Project coordination/leadership experience with a proven track record of delivering quality results
  • Excellent knowledge of QbD process development, scale-up, technology transfer, process validation, and CMC regulatory affairs
  • Strong analytical skills with hands-on experience in data management, data processing, and data analytics
  • Ability to interpret, visualize, and communicate complex project data to stakeholders

What We Offer:

  • A competitive salary: $120,000 - $150,000 per year
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A comprehensive benefits package

Location: Our office is located in [insert location]. While we prefer candidates based in this location, we are open to remote work arrangements for the right candidate.



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