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):
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 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).
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 & regulatory expectations/requirements
ü Ensure work activities are aligned with relevant Quality, Regulatory and EHS requirements.
ü Ensure compliance with DAFF biosecurity requirements for ordering and handling relevant raw materials.
Education and experience
ü 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.
ü Experience/ advanced knowledge of parenteral formulations development for biologics
ü Advanced understanding of protein chemistry, degradation pathways, and general approaches for stabilisation
ü Advanced knowledge of biophysical techniques and ability to apply them for characterisation and problem-solving during formulation development
ü Ability to independently contribute from the bench
ü Ability to coach and train others in the design, execution and interpretation of experiments to drive the definition and optimisation of formulations
ü Impeccable record keeping
ü Excellent oral and written communication skills and ability to contribute in a cross functional environment
ü Excellent understanding of Good Manufacturing Practice.
Full time
Regular
Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from…