BIOPHARMACEUTICAL PRODUCT DEVELOPMENT (Therapeutic Antibodies)Downstream Project lead for process development of three novel monoclonal antibodies and fusion protein process and product development.Clone selection to process optimization and scale up to technology transfer and support in production. Scale up and SDM.SME for downstream process development and QMS related activities.Handling team of five with respect to three different projects.

Biological Product Development from Cell culture based Vaccines and monoclonal antibodies.Purification of biomolecules from Cells and strategic improvement of yield in continuous process development.

Documentation perparation as per WHO guidelineBMR, SOP, Protocol preparations, reviewHandling QMS related activities like deviation, change control, risk assessment, CAPA.Manpower managementMaterial Handling and ManagementSAP related activity for Facility ManagementGMP facility maintenance and compliance as per WHO guideline

Fermentation based Recombinant Vaccine biomolecule projectsUSP and DSP process development for Recombinant Vaccine molecules like HBsAg,HPV bi and tetravalent,TCV Yield improvementTechnology Transfer and production.Downstream process for the purification of desire product from the fermented broth,like different biologics and recombinant protein molecules.Handling Of Purification tools like Continuous Centrifuge Westfalia,Cell washer Westfalia, Cell Disruptor Microfluidics,Akta Purification Units, Ultracentrifuge K2Mark, TFF units of Sartorius and Millipore,PallHandling QMS related activities like deviation, change control, risk assessment, CAPA.Manpower management,Material Handling and Management,SAP related activity for Facility Management.Cross-functional activities to meet timeline for process development.Egg based Vaccine Production like Flu Vaccine

Fermentation process for the production and development of various antibiotics and anticancer active pharmaceutical ingredients at production scale. day to day management of batch production, planning and execution for the smooth working through out the day and night shifts.Media Preparation,Media sterilizationFermenter SterilizationCulture InoculationBatch Control through SCADA based SoftwareBatch Harvest,Batch Harvest transfer to Recovery department.Raw material management,manpower management,Documentation as per USFDA, EU GMPProduct handled,1 Mupirocin2 Mycophenolic Acid3 Romidepsin4 Penicillin GSuccessful completion of USFDA and EU GMP Routine Audits.