Director, Global Pathogen Safety

About CSL

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!

Job Description

Job Purpose:

The purpose of this position is to be the Global Pathogen Safety (GPS) responsible for Seqirus to provide pathogen safety (PS) support for all of Seqirus' vaccines as well as antivenom/antitoxin immunoglobulin products manufactured in Holly Springs (NC, USA), Liverpool (UK) and Parkville (VIC, Australia). Therefore this role can be based at any of these primary locations.

Seqirus is a CSL company, and this position will report into the Head of CSL Behring Global Pathogen Safety, as well as dotted-line into the Head of Technical Development at Seqirus.

Major Accountabilities:

Be the go-to person for pathogen safety of all Seqirus products:

• Be responsible for the pathogen safety control strategy for Seqirus products from selection of starting materials, testing strategies and pathogen reduction steps to assure final product safety for patients
• Build and maintain matrix relationships partnering across the Seqirus organization (with interface functions such as Technical Development, MS&T, Quality Assurance, Clinical, Regulatory, Pharmacovigilance, Commercial, Corporate Communications)
• Advise on development of pathogen reduction steps using a Quality by Design approach in collaboration with Technical Development for clinical and licensed Seqirus products
• Advise on development and qualification of relevant scale-down models for pathogen reduction steps
• Oversee validation of virus reduction capacity of pathogen reduction steps performed by CROs or internally to meet all relevant global regulators expectations
• Perform emerging pathogen surveillance and initiate studies supporting product safety relating to emerging viruses, as needed
• Provide pathogen safety (PS) expertise to all Seqirus manufacturing sites including change control and manufacturing incident assessments, segregation risk assessments, and audit support
• Own pathogen safety information included in regulatory filings and in responses to pathogen safety-related questions from health authorities and support audits
• Become internally recognized as the primary support for general matters related to PS across the Seqirus organization
• Lead global PS projects that support PS-related business needs for Seqirus
• Drive innovation in the domain of pathogen safety for Seqirus

Be part of the Global Pathogen Safety leadership team at CSL representing Seqirus:

• Partner with the corresponding Leads within CSL Behring's Global Pathogen Safety to share and leverage expertise, knowledge and systems, and to build synergies
• Represent GPS leadership in global projects or initiatives within CSL
• Support GPS leadership in the maintenance of relationships with regulators and other stakeholders on PS-related topics as well as in enhancing visibility of CSL as a leader in PS

Minimum Requirements:

• Ph.D., Masters, or BS (or equivalent) in Virology, Biochemistry, Biology or related field
• Minimum 10 years of experience in vaccine or biologicals R&D, Pathogen Safety, Quality Management, or similar.
• Strong preference for industry experience in pathogen safety or viral clearance; experience with either sterility assurance or process development may be considered if directly applicable;
• Strong leadership skills to work in a global matrix setting, understand needs of customers/stakeholders, use proactive approaches to meet their needs in an effective and timely manner, and to build and maintain effective working relationships
• Excellent communicator, capable of building collaborative working atmosphere, with cross-cultural sensitivity and flexibility to work in global teams (including willingness to participate regularly in global teleconference meetings outside local business hours)
• Results-orientation in combination with attention to detail and quality
• Fluent in English