Ipca Laboratories Limited | AGM
1 month ago
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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