AGM - Biotech Formulation Development For Liquid And Lyophilized Drug Product

Hiring for Sr. Manager / AGM for Biotech Formulation process development for liquid and lyophilized drug product.

Department : Advance Biotech Lab

Job Location : Mumbai

Qualification Required : M. Pharma, M.Sc. PhD, M.Tech

Experience : 12+ yrs of relevant experience as per JD mentioned below

:

• Responsible for Biologics formulation development, development of new formulation liquid and lyophilized product, overall lab supervision to achieve project targets by delivering and improving drug product process.
• Drug Product Process Development and Technology transfer to Manufacturing/CMO (cGMP) and ensuring its successful replication/scale up.
• Formulation process development for liquid and lyophilized drug product
• Involve in equipment qualification and calibration activities.
• Active participation in internal audit, vendor / service provider audit and CMO audit.
• Manufacturing support for handling deviation, Change control and Investigations, Root cause analysis, CAPA etc.
• DOE based process development for lyophilized / liquid drug product
• Stability study plan for drug product, FT cycle development for DS and forced degradation study for DP along with analysis of DP samples
• Compilation of data for presentations and report preparation
• Involve in Maintenance of Lab Equipment, Materials/Consumables
• Support to lab management activities as per project/compliance requirements.
• Assessment of primary container closure and device for final DP