CMC Lead Recombinant

At CSL our purpose is to deliver lifechanging 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 crossfunctional program delivery - leading matrix teams shaping CMC strategy and ensuring highquality phaseappropriate CMC packages that support timely development and regulatory success.

Your 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 phaseappropriate 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 endtoend oversight of manufacturing delivery including production validation contracts and regulatory activities with sites and partners
• Accountable for qualityrelated 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

Your Skills and Experience:

• A bachelors 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 (plasmaderived or biotech products preferred)
• Proven experience supporting regulatory submissions and technical regulatory writing
• Demonstrated ability to lead by influence across global crosssite project teams
• Excellent problemsolving skills strategic focus and clear communication style
• Experience working in international multisite development environments

Why Join CSL

• Purposedriven work delivering therapies that make a real difference
• Global scale with worldleading expertise in recombinant and biological products
• Highimpact roles at the centre of development and regulatory strategy
• Collaborative scienceled culture with strong crossfunctional partnerships

Apply now to lead CMC strategy and drive the successful development of CSLs lifesaving Recombinant therapies.

Applications Close April 16 2026

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit