About the job
The CMC Lead – Immunoglobulins (Ig) & Inframarginals at CSL is a pivotal job that focuses on delivering life-changing therapies to patients worldwide. This position plays a crucial role in leading cross-functional program delivery, shaping CMC strategy, and ensuring high-quality, phase-appropriate CMC packages that support timely development and regulatory success. The team thrives on collaboration and innovation, working together to achieve impactful results.
You'll be responsible for
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Leading CMC matrix teams
Lead CMC matrix teams across assigned programs, ensuring delivery of process, analytical, and manufacturing plans aligned to development milestones⚙️
Defining manufacturing strategies
Define and execute manufacturing strategies, including clinical supply planning in early development📊
Delivering control strategies
Deliver phase-appropriate control strategies and contribute to product specifications in partnership with technical expertsKey criteria
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10+ years in pharmaceutical industry
Experience in manufacturing operations, process design, and validation.View
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Regulatory submission expertise
Proven experience supporting regulatory submissions and technical writing.View
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Global project leadership
Demonstrated ability to lead cross-site project teams effectively.View
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