Director, Drug Product and Stability 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

Pharmaceutical Sciences, Formulation Development, Manufacturing Processes, Technology Transfer, Stability Program Design, Regulatory Compliance, Leadership, People Management, Risk Management, Statistical Approaches, Commercial Product Launches, Lifecycle Management, Drug Product Development, Quality Assurance, Clinical Development, Health Authority Interactions

Industry

Pharmaceutical Manufacturing

Description

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) Your Skills & Experience: 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 Apply now and help shape the future of drug product development and stability at CSL. Applications close: 16 April 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 the strategic and operational oversight of drug product development and stability programs across the product lifecycle. Partner closely with various teams to ensure robust formulation design, regulatory compliance, and long-term product quality.