Junior Manager

Syngene

6 - 10 years

9 - 10 Lacs

bengaluru

Posted:8 hours ago| Platform:

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Skills Required

dsp data management nutrition chemical engineering pharma process control downstream processing packaging consumer goods auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Provide input to Downstream for improvement of products/process.
Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department.
Downstream batch plan preparation as per campaign schedule.
Supervise commissioning and qualification activity of BMP1 DSP related equipment.
Preparation of micro batch schedule and shift planning for day-to-day activities.
Monitor and follow good aseptic behaviour inside the BMP1 facility.
Support in audit and audit closure points.

Involve in shipment of samples / final product as per packing and dispatch record.
Preparation of BMRs, SOPs, IOPs & EOPs, general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents.

Supervise Downstream activities of buffers preparation, Harvest, purification, and final filtration,
Calibration of operations equipment.
Monitoring and process control of specific operations of downstream.
Compliance to current good manufacturing practices.
Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required.
Perform room owner responsibility for the assigned DSP area.
Maintain facility and assigned zone all-time ready for visit and audit.
Involve in Shipment of samples /final product as per packing and dispatch record.
Review of executed Documents on time.

Education and Experience

Education

Graduate or Master s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.

Industry Experience

Minimum 6 - 10 years of relevant practical experience in Downstream process Production for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc.

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