AGM - Biotech Formulation Development for liquid and lyophilized drug product

2 months ago


Mumbai, India Ipca Laboratories Limited Full time
Hiring for Sr. Manager / AGM for Biotech Formulation process development for liquid and lyophilized drug product.Department

: Advance Biotech LabJob Location

: Mumbai

Qualification Required

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

Experience

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

Job Description :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 productInvolve 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 productStability study plan for drug product, FT cycle development for DS and forced degradation study for DP along with analysis of DP samplesCompilation of data for presentations and report preparationInvolve in Maintenance of Lab Equipment, Materials/ConsumablesSupport to lab management activities as per project/compliance requirements.Assessment of primary container closure and device for final DP



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