Director, Drug Product and Stability

At CSL, our purpose is to deliver life-changing therapies to patients around the world. We're seeking an experienced Director, Drug Product & Stability to lead the strategic and operational oversight of drug product development and stability programs across the product lifecycle, from early development through to commercial delivery.

This is a pivotal leadership role, partnering closely with CMC, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure robust formulation design, regulatory compliance, and long-term product quality.

As Director, Drug Product & Stability, you will:

• Lead drug product development and stability strategy across the product lifecycle, from early development through to commercialisation
• Oversee formulation development, process development, scale-up, and technology transfer to manufacturing sites
• Ensure drug products are robust, manufacturable, high quality, and compliant with global regulatory requirements
• Design, govern, and approve stability programs, protocols, reports, and shelf-life assignments in line with ICH guidelines
• Ensure stability data supports clinical development, regulatory submissions, and commercial supply
• Contribute to CMC sections of global regulatory filings and support health authority interactions and inspections
• Partner cross-functionally with CMC, Quality, Regulatory, Manufacturing, Supply Chain, and Technical Operations to support lifecycle management and continuous improvement
• Lead, develop, and mentor high-performing scientific teams while managing budgets, resources, and external partners (CMOs/CROs)

• PhD, MS, or equivalent in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related discipline
• 12 -15+ years' experience in pharmaceutical drug product development
• Demonstrated leadership and people management experience
• Strong knowledge of formulation development, manufacturing processes, and technology transfer
• Deep expertise in stability program design and regulatory expectations
• Proven experience supporting global regulatory submissions and health authority interactions
• Solid understanding of QbD, risk management, and statistical approaches
• Experience supporting commercial product launches and lifecycle management