Assistant/Deputy Manager - Biosimilars Downstream Manufacturing

Company Overview:

Biocon Biologics is a leading global biopharmaceutical company dedicated to improving patient access to high-quality, affordable biotherapeutics. With a commitment to innovation, quality, and ethical practices, Biocon Biologics is at the forefront of developing and delivering transformative healthcare solutions. As a pioneer in the biotechnology industry, we strive to make a positive impact on the lives of patients worldwide.

Responsibilities:

• Planning, executing, monitoring, and controlling the Solubilization, Pegylation, UF/DF & DS operations as specified in the BMRs / SOPs
• Operation of equipment like surge vessel, blender, magnetic stirrer, mixer, CIP skid, neutralization tank, fume hood scrubber, TFF, mixing glass vessel, biosafety cabinet, Dynamic Pass box & weighing Balances / Scales (Not limited to).
• Operation & verification (If applicable) of Analytical instruments like pH & conductivity meter, spectrophotometer & filter integrity testing machine (Not limited to).
• Involving in buffer / solution filtration activities
• Preparation and filtration of excipients used in the DS process.
• Transfer of final DS to other facilities as specified in the BMR/ SOPs.
• Storage of cassettes & replacement of storage solutions.
• Initiation of notifications in SAP for instruments/equipments breakdown & follow-up.
• Operation of devices like Calculators & Barcode Scanning System (Not limited to).
• Verification, receiving, transfer & process wise / stage wise segregation of BOM materials.
• Completion of trainings before the execution of activities.
• Adherence to SOP and good manufacturing practices.
• Updating of process material consumption in SAP & return of unused materials through SFR if any.
• Ensuring the equipment / instruments are within the Preventive maintenance & Calibration due dates and witnessing the Preventive maintenance and calibration activities.
• Routing movement of material on shop floor appropriately.
• Sequencing the procedures and processes which are taking place on shop floor.
• Identifying the procedural gaps and addressing the same.
• Submission of samples to Quality units.
• Documenting the operations in appropriate sections of the documents by following GDP.
• Identifying and reporting the non-conformities / Events and coordinating in investigating the same for the identification of root cause.
• Responsible to draft first cut information for deviations, proposal for change control and implementation of CAPAs to ensure high quality GMP standard.
• Complying with QA & EHS procedures.
• Identifying and reporting the EHS related non-conformities / Incidents and coordinating in investigating the same for the identification of root cause.
• Maintaining appropriate clean room behaviours, health & hygiene practices and regularly following personnel entry/exit procedures in shop floor.
• Escorting the visitors as per the SOP.

Qualifications:

• B.Tech/BE/MSc (Biotechnology/Bio Chemistry)
• 8+ years' of experience in Biopharma Manufacturing