The CMC Lead position at CSL Behring is focused on leading project-specific Chemistry, Manufacturing, and Control (CMC) teams to ensure the timely delivery of CMC packages throughout clinical development and market authorization. The ideal candidate should possess extensive experience in the pharmaceutical industry, strong project management skills, and a deep understanding of CMC principles relevant to biological manufacturing
Job Summary
This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams.
The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM).
CSL Seqirus is part of CSL and is a major contributor to the prevention of influenza globally.
Matching Summary
Match Score: 85
The CMC Lead position at CSL Behring is focused on leading project-specific Chemistry, Manufacturing, and Control (CMC) teams to ensure the timely delivery of CMC packages throughout clinical development and market authorization. The ideal candidate should possess extensive experience in the pharmaceutical industry, strong project management skills, and a deep understanding of CMC principles relevant to biological manufacturing.
Skills & Requirements
Must-have
Lead CMC project teams
Define phase-appropriate control strategies
Author and review CMC regulatory submissions
Deliver Quality Section for submissions
Maintain line-of-sight to manufacturing delivery
Communicate CMC strategies and objectives
Nice-to-have
Proactive, solution-oriented approach
Continuous improvement on best practices
Strong problem-solving capabilities
Ability to manage multiple priorities
Key Requirements
10+ years of pharmaceutical industry experience
Experience in manufacturing operations, process design, and validation
Demonstrated project management and/or leadership by influence
Advanced knowledge of biological manufacturing processes
Technical and regulatory writing experience
Experience working across sites and international teams