Role-specific:
Maintain good aseptic behavior inside BMP1 facility.
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 µ 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.
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.
Execute the protocols related to Downstream related activity and equipment / instrument qualification.
Involve in Shipment of samples /final product as per packing and dispatch record.
Execute the batch activity as per BMR and report nonconformity to the supervisor.
Issuance of annexures, RM, consumables and BMRs.
Track the work order status and ensuring timely closure.
Education and Experience
Education
Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
Industry Experience
- Minimum 0-4 years of relevant practical experience in Downstream Manufacturing for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc.