DNYANESHWAR BHAND

• Leading a team dedicated for process characterization studies starting from the large scale batches data compilation and analysis, Process risk assessment using FMEA to identify Potential critical process parameters to be subsequently studied using DoE for process characterization.
• Leading a team of Upstream scientists involved in gamut of USP activities for smooth tech transfer at scale
• Support for upstream process scale-up to 2500 L scale
• Risk assessment and gap analysis
• Process scale up, tech transfer and risk mitigation
• Statistical data interpretation and analysis
• Team building and mentorship
• Collaboration with external partners for study execution

● Process optimization to address the scale-up challenges, technology transfer and establishment of process consistency and quality across the scales (10L, 50L, 200L & 1000L SUB

● Supervised junior technicians and scientists.

● Large scale (50L & 200L SUB) bioreactor characterization, mass transfer and mixing time studies

● Experience in cGMP operations for generation of material for clinical trials.

● Well versed with application of DOE principles and multivariate data analysis by effective utilization of various software like JMP®, MODDE® and Design-Expert®

● Risk assessment (FMEA) and mitigation for cell culture process development and process characterization studies.

• Lead a team of 4 Scientists for the Clone evaluation and selection, media and feed screening, optimization of process parameters to improve productivity and match biosimilarity, process transfer, scale-up to 50L and 500L SUB activities of the CHO cell culture based anti-TNF monoclonal antibody for the treatment of moderate to Severe Rheumatoid arthritis.
• Expertise in designing and execution of bioreactor level experiments for process optimization and for preclinical/clinical studies.
• Designing and execution of media/feed screening in ambr15 and for improvement of product quality and titer using DoE statistical approach.
• Authored technical reports and technology transfer documents for the developed processes.
• Preparation of protocols, process development summary, scale up report and characterization documents.
• Establishment of scale-up/scale-down model, technology transfer to manufacturing.
• Led/ co-led and contributed to continuous improvement projects for productivity enhancement and reduced CoG's for mabs & recombinant therapeutic protein in commercial manufacturing.
• Responsible for Lab management and implementation of new systems including new equipment DQ, IQ, OQ & PQ with the GLP guidelines.

• Worked on “Development of fungal secondary metabolites as novel biopesticides using submerged fermentation”.
• Contributed to and actively participated in research conception, design and execution to address defined problems.
• Maintained accurate records of research findings and provided statistical analysis of data results.