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JOB SUMMARY
The Formulation Scientist under the direction of Process Development Director is responsible for the development and optimization of product formulations and the implementation of manufacturing processes. They perform this function in accordance with the GMP and FDA standards applicable to the target market and the quality criteria established by the company.
JOB DUTIES
Development of product formulations in solution, suspension, emulsion and lyophilized forms for small molecules and biological products (mAb: monoclonal antibodies; ADC: antibody drug conjugate; proteins, peptides, oligonucleotides and high potency products).
Define and update the QTPPs and CQAs of the formulation: efficacy, safety, stability, purity and potency, etc.
In partnership with the client aid in the selection of suitable form of API for final drug product through pre-formulation and formulation techniques e.g. polymorph, i...