About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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

An exciting fixed term position has become available at our Parkville (Australia) site for a Nonclinical and Clinical Batch Release Lead to join our Global R&D Quality team. In this position you will be responsible for the release of material for GLP toxicology studies and clinical trial material and provide strategic support globally as an expert in assuring quality during R&D, arranging audits of third party suppliers/venders/CROs/CMOs for supplier qualification, deviations and changes involving R&D activities and product technical complaints.

You will be the global R&D QA single point of contact for the sterile manufacture, packaging, labelling, testing and release of material for GLP toxicology studies and clinical trial material, across all R&D programs and internal/external facilities/areas for products being developed in the Australia and Asia/Pac region. You will also be the go-to Subject Matter Expert in the quality requirements for product development and GxPs that apply, supporting compliance with all applicable SOPs, regulatory requirements and guidance in collaboration with R&D QA and other global Quality functions:

The successful candidate must possess:

• Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy).
• Quality Assurance and/or GMP regulated environment experience within the pharmaceutical industry.
• Sterile product manufacturing knowledge and experience in aseptic processing in Biologics
• Experience working directly within or directly supporting a clinical or commercial manufacturing environment.
• Raw Material, Drug Substance and Drug Product expertise in vaccines preferred
• Experience working across different phases of R&D preferred (Early phase Product Development/GLP Toxicology, Clinical Phse 1, 2 and 3 and commercialization)

In addition the ideal candidate would possess.

• Deep understanding and demonstrated application of cGxP as it relates to new product development.
• Advanced knowledge of
  • Sterile product manufacturing, biological processes, raw materials and laboratory operations
  • Phase appropriate quality systems, including Quality by Design principles
  • Manufacturing process and analytical method qualification/validation
  • Supplier / third party audits and management
• Experience with vaccine development / cell culture platforms.
• Understanding of Australian/AsiaPac regulatory CMC and GxP requirements, and the applicability to early development programmes. Experience with FDA/EU requirements a plus.
• Leadership competencies in making difficult decisions, relationship-building, influencing, fostering teamwork, and knowledge of the business to exercise sound judgment
• Strong analytical and practical problem solving skills
• Ability to negotiates, engage and influence stakeholders at all levels to be able to make objective decisions based on risk management principles and provide sound justification;
• Tech Transfer experience.
• Organised, driven and able to concurrently manage multiple tasks with competing priorities, including projects across functional groups and business units;

If you are looking to develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-121486

Applications will close on Monday 24th August 2020