Description Formulation Specialist Position summary and key responsibilities The incumbent will be working as part of specific project teams and is responsible for the design and execution of pre-formulation, formulation and process optimization studies, including scale-up, manufacture of clinical supplies, and technology transfer to pilot/manufacturing facilities.
The role involves close collaboration with cross-functional stakeholders and contributing to technical and regulatory documentation.
The selected individual is expected to have knowledge of formulation, adjuvants, stabilization of vaccines/biological products and familiarity with biological assay methods.
Key responsibilities include (but not limited to): ü Development of vaccine formulations · Good understanding of Master seed systems · Obtaining antigen and concentration techniques · Ordering raw materials and an understanding of Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity requirements · Develop and optimize vaccine formulations for technical, pivotal and validation studies.
· Plan and execute pre-formulation studies, including manufacture of technical batches.
· Define formulation parameters and support assay validation activities.
· Support antigen concentration process development, qualification and transfer to Manufacturing.
· Coordinate submission of samples for QC testing (Zoetis Melbourne QC, overseas Zoetis sites, and external contract laboratories).
· Overseeing purchase and qualification of current raw materials for production of Pre-licensing serials (PLSs) · Oversee PLS manufacture at scale in the manufacturing plant.
· Co-ordinating the activities required to formulate batches in the Manufacturing plant · Transfer of the defined manufacturing process to Manufacturing plant for commercial manufacture · Act as the formulation SME for facility construction/expansion teams (as required).
ü Collaborate with technical teams including Process Development, Biological Research, Clinical, Regulatory, Project Management, Quality Control, Quality Assurance, Engineering and Manufacturing ü Author technical protocols/reports and contribute to regulatory documents ü Keep abreast of relevant new technologies