AGM - Biotech Formulation Development for liquid and lyophilized drug product

1 month 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 Lab

Job 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 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



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