Upstream Manufacturing

Syngene

2 - 10 years

6 - 10 Lacs

bengaluru

Posted:16 hours ago| Platform:

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Skills Required

molecular biology project management upstream sap production downstream processing downstream protein purification research refinery oil operations procurement chromatography ariba petroleum ariba buyer petrochemical

Work Mode

Work from Office

Job Type

Full Time

Job Description

Follow good aseptic behaviour inside Biologics operations facility.
Perform all the upstream activities like Assembly preparation, Media Preparation, Vial thaw, Feed preparation and filtration, Bioreactor Operations to Batch Harvest.
Monitoring and process control of the specific Operations of the upstream.
Maintenance of Quality records.
Traceability from raw material till finished product.
In-process product sampling and storage.
Preparation and review of operation related documents.
Perform room owner responsibility for the assigned USP area.
Perform equipment/instrument ownership related responsibilities related to USP.
Initiate Complaint Slips (work orders) for USP related areas and equipment.
Coordinate with QA for line clearance.
LNS system monitoring and LN2 tank refilling.
Gas Bank Monitoring.
Maintaining process area All-time ready for Inspection/ audit purpose.
Preparation of general upstream related procedures, protocols, risk assessment and BMRs.
Execution of protocols related to upstream related activity and equipment / instrument qualification.
General consumable stock review and record maintenance
Ensure PM planner and calibration planner are followed.
Execution of batch activity as per BMR and report nonconformity to the supervisor.
Issuance of annexures, RM, consumables and BMRs.
Tracking of work order status and ensuring timely closure.
Involve in downstream related activities under supervision of downstream supervisor.

Education and Experience

Education

Master s degree/ bachelor s degree in pharmacy, Master s degree in Pharmaceutical Sciences.

Industry Experience

Minimum 2 -10 years of relevant practical experience in mAbs downstream process.

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