Roles and Responsibilities
Greetings from BVR People Consulting!!
Candidate should have experience in R&D (Drug Product) Formulation development (Biosimilars/ Biologics).
The candidate should be well-versed in the area of drug product development. He/she should have experience in conc protein stability, knowledge of higher order structure and its role on product stability
The candidate should have knowledge on drug product formulation development. He/she should have knowledge formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc.
The candidate should have basic knowledge of various container closure systems such as vials, pre-filled syringes.
The candidate should have experience in running stability programs which include temperature, forced
The candidate should have knowledge on product quality estimation techniques such as HPLC, CE-S the data generated.
The candidate should have knowledge of particle characterization techniques and biophysica The candidate should be well-versed in basic statistics and should have experience in usi
The candidate should have basic knowledge of regulatory guidance from USFDA, EMA
The candidate should have experience in developing drug product related data.
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