Position : Senior Manager - Production (Downstream)

Team Size : 18

Position Reports to : HOD - Production (Upstream & Downstream)

Plant Details : Drug Substance Biologics Manufacturing Plant

Facility : Microbial

Regulatory Approvals : EMA, MHRA, ANVISA, SFDA, Health-Canada.

Job Responsibilities:
To manage day to day activities of downstream operations and activities to be performed as per laid down procedures, which are complying with current cGMP norms.
Scheduling of the downstream batches
Reduction of operational cost by evaluating current process requirements, evaluating process, evaluating alternate vendor development
Analyses of repetitive failure and to provide solution/ develop procedures to bring repetitive deviations under control.
Review of equipment performance over a period of time and proactively to take action before failure happens.
Assure that Preventive maintenance, calibration and validation activities are carried out within defined frequency and batches are planned without deviating timelines.




Ensure the availability of Raw material and Packing material at all times in synchronization with business plans.
To ensure that downstream facility and documentation is always in a state audit readiness.
Review of downstream activities which can become potential data integrity issue and laid down procedure / simplify activities for ease to record activities.
Review of downstream documents record as per technicality and following procedure/ compliance laid down by site.
Review the deviations, change controls, CAPA and other quality management system.
Review of MFR, BMR, SOPs, Protocols, reports and other process related documents.
Assure EHS polices are followed in compliance to current norms in the manufacturing area.
To monitor performance and guide team member to have smooth flow of working for day-to-day activities.
Co-ordination with stake holders-QC, QA, Engineering, Supply Chain Management, Purchase, Safety Department etc.
Work in close coordination with R and D for taking development batches / current projects.

📌 Senior Manager Production Downstream Ds Biologics Plant Maharashtra
🏢 USV
📍 Maharashtra