CMC Lead - Recombinant

CSL

1d

About The Position

At CSL, our purpose is to deliver life‑changing therapies to patients worldwide. We are seeking a CMC Lead – Recombinant to provide strategic and operational leadership across Chemistry, Manufacturing and Controls (CMC) activities for clinical development, market authorisation, and lifecycle management programs. This role sits at the centre of cross‑functional program delivery - leading matrix teams, shaping CMC strategy, and ensuring high‑quality, phase‑appropriate CMC packages that support timely development and regulatory success.

Requirements

• A bachelor’s degree in a relevant scientific or engineering discipline (advanced degree strongly preferred)
• 10+ years’ experience in the pharmaceutical industry, with emphasis on manufacturing operations, process design, and validation
• Strong knowledge of biological manufacturing processes and advanced CMC/QbD requirements (plasma‑derived, or biotech products preferred)
• Proven experience supporting regulatory submissions and technical regulatory writing
• Demonstrated ability to lead by influence across global, cross‑site project teams
• Excellent problem‑solving skills, strategic focus, and clear communication style
• Experience working in international, multi‑site development environments

Responsibilities

• Lead CMC matrix teams across assigned programs, ensuring delivery of process, analytical, and manufacturing plans aligned to development milestones
• Define and execute manufacturing strategies, including clinical supply planning in early development
• Deliver phase‑appropriate control strategies and contribute to product specifications in partnership with technical experts
• Author, review, and support CMC sections of regulatory submissions across development, market authorisation, and lifecycle management
• Maintain end-to-end oversight of manufacturing delivery, including production, validation, contracts, and regulatory activities with sites and partners
• Accountable for quality‑related CMC deliverables and QbD documentation such as risk assessments, PFMEAs, and monitoring strategies
• Communicate CMC strategy, progress, and risks effectively across IPTs and stakeholder groups
• Drive alignment and continuous improvement of CMC and QbD best practices across programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees