CMC Quality By Design Expert
vor 1 Tag
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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