Downstream Production

Role & responsibilities

Role-specific:

• Perform all the Downstream activities like Assembly preparation, accessories arrangement for step, Dispensing of raw materials and consumables, Reconciliation of excess and unused raw materials and consumables Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation and 0.2 filtration.
• Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP.
• Monitoring and process control of the specific Operations of the Downstream.
• Maintenance of Quality records.
• Perform In-process product sampling, sample submission and storage.
• Preparation and review of operation related documents.
• Perform room owner responsibility for the assigned DSP area.
• Perform equipment/instrument ownership related responsibilities related to DSP.
• Initiate Complaint Slips (work orders) for DSP related areas and equipment.
• Coordinate with QA for line clearance.
• Maintaining process area All-time ready for Inspection/ audit purpose.
• Maintain facility and assigned zone all-time ready for visit and audit.
• Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record (BMR).
• Involve in shipment of samples / final product as per packing and dispatch record.
• Work proactively to meet all document(s) on time closure requirement.
• Preparation of general Downstream related procedures, protocols, risk assessment and BMRs.
• Execute the protocols related to Downstream related activity and equipment / instrument qualification.
• Involve in Shipment of amples /final product as per packing and dispatch record.
• Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required.
• Execute the batch activity as per BMR and report nonconformity to the supervisor.
• Review of executed Documents on time.
• Issuance of annexures, RM, consumables and BMRs.
• Track the work order status and ensuring timely closure.

Involve in Downstream related activities under supervision of Downstream supervisor.

Education

Masters degree/ bachelors degree in pharmacy, Masters degree in Pharmaceutical Sciences.

Industry Experience

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