CMC Lead (Ig and Inframarginals) at CSL

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

29 Jun, 26

Salary

0.0

Posted On

31 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Manufacturing Operations, Process Design, Validation, Regulatory Submissions, Technical Regulatory Writing, Problem-Solving, Strategic Focus, Communication, Biological Manufacturing Processes, Quality by Design, Clinical Supply Planning, Risk Assessments, Monitoring Strategies, Cross-Functional Collaboration, Continuous Improvement

Industry

Pharmaceutical Manufacturing

Description

At CSL, our purpose is to deliver life‑changing therapies to patients worldwide. We are seeking a CMC Lead – Immunoglobulins (Ig) & Inframarginals 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. 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 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 Your Skills and Experience: 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 (Ig, 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 Why Join CSL? Purpose‑driven work delivering therapies that make a real difference Global scale with world‑leading expertise in Ig and biological products High‑impact roles at the centre of development and regulatory strategy Collaborative, science‑led culture with strong cross‑functional partnerships Apply now to lead CMC strategy and drive the successful development of CSL’s life‑saving Ig 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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our 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 https://www.csl.com/careers/inclusion-and-belonging Equal 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 https://www.csl.com/accessibility-statement. 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 click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

Lead CMC matrix teams to ensure delivery of process, analytical, and manufacturing plans aligned to development milestones. Author and support CMC sections of regulatory submissions while maintaining oversight of manufacturing delivery.