Global Method Transfer Lead

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

The Global Stability Strategy Lead will support the development of a global center of excellence with best practices, strategies and framework for process Tech Transfers supporting biopharmaceutical manufacturing across CSL Behring.

Responsibilities:

• Develop global COE with best practice strategies and framework for method Tech Transfers
• Assist in harmonization of analytical technologies in support of commercial processes across multiple sites. 
• Standardized/templated ways of working owned and implemented by global team
• Implement “Fit for Purpose” methods demonstrating broad understanding of Method validation and transfer
• Oversight of CMO ensuring CSL standards are upheld
• Provide leadership and direction for implementing new standards, cultural change and harmonization across global sites
• Support initiatives by operating a flexible manner demonstrating global thinking with strong site presence
• Review the technical content in the Tech Transfer analytical sections of regulatory dossiers
• Establish and maintain a culture of learning and continuous improvement through capturing lessons learned and enabling cross-project collaboration

Qualifications:

• Undergraduate degree in Biochemistry, Chemistry, Microbiology or other related technical field. 
• 7+ years working in development and commercialization of methods for biopharmaceutical products and processes with 2+ years of experience in Quality Control
• Strong priority setting, negotiating and conflict management skills
• Experience in organizing, developing and deploying best practice frameworks, processes, tools and templates.
• Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.