The incumbent will be responsible for preparing buffer and formulation solutions, conducting protein sample analysis using different analytical techniques, including HPLC, Microflow imaging, HIAC, spectrophotometry, NIR, etc.
The associate will be responsible for study design of frozen bulk process development, such as freeze thaw, compatibility, and stability experiments. Experimentation may include scale down modelling of frozen bulk systems. Additional studies may include fill finish process development (e.g. mixing, filtration, effect of fluid flow, and lyophilization).
Responsible for the late stage biopharmaceutical formulation/fill finish process development, process scale up, and technology transfers to manufacturing or CMO. This multi-disciplinary team interacts intensively with many functional groups, including early formulation, process development, analytical, regulatory, clinical, and commercial manufacturing, for the pipeline product development.
The candidate has to be self-motivated, with three or more years of experience, with a good understanding of protein biochemistry and biophysics
Source: Job Diva – Job Listing