About this role
Formulation Scientist
Role 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):
Development of vaccine formulations
Good understanding of Master seed systems
Obtaining antigen and concentration techniques
Ordering raw materials and an understanding of 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 and external contract laboratories.
Overseeing purchase and qualification of new 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).
Collaborate with technical teams including Process Development, Biological Research, Clinical, Regulatory, Project Management, Quality Control, Quality Assurance, Engineering and Manufacturing
Author technical protocols/reports and contribute to regulatory documents
Keep abreast of relevant new technologies & regulatory expectations/requirements
Ensure work activities are aligned with relevant Quality, Regulatory and EHS requirements.
Ensure compliance with DAFF biosecurity requirements for ordering and handling relevant raw materials.
Education and experience
B.Sc. (10+ years of relevant experience) or M.S or PhD (2 to 5 years of industrial experience) in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering or related field with research focus on formulation related issues with monoclonal antibodies, proteins, peptides, or vaccines.
Experience/ advanced knowledge of parenteral formulations development for biologics
Advanced understanding of protein chemistry, degradation pathways, and general approaches for stabilisation
Advanced knowledge of biophysical techniques and ability to apply them for characterisation and problem-solving during formulation development
Ability to independently contribute from the bench
Ability to coach and train others in the design, execution and interpretation of experiments to drive the definition and optimisation of formulations
Impeccable record keeping
Excellent oral and written communication skills and ability to contribute in a cross functional environment
Excellent understanding of Good Manufacturing Practice.
Full time