Hrishikesh Bartake, Ph.D. Email & Phone Number

India

Pune, Maharashtra, India

● Conducted computer systems validation (CSV) for various GMP equipment such as chromatography systems, bioreactors, fermenters, robotic platforms, virus filtration system, TFF system. ● Experience in designing, qualification and validation of manufacturing automation systems/software- PLC, SCADA● Preparing, review & approval of computer system validation documents- URS, Functional design specifications for manufacturing systems implementation at Enzene manufacturing sites.● Leading team to perform acceptance tests- FAT, SAT, qualification- Installation, Operation and Performance Qualification for various manufacturing equipment. ● Spearheaded the design team for implementation of greenfield project to develop fully continuous bioprocessing platform process automation, resulting in a manufacturing capability for 3 biosimilar products. Providing strategy, planning, managing and overseeing the deployment of the project.● Technology evaluation, implementation & validation of temperature monitoring and alarm system. Integration of the system within our virtualized IT setup & network. ● Implementation of Sartorius MFCS software in virtualized IT environment, resulting in significant IT hardware cost reduction. ● Designed and developed automated computer controlled remote client access system for cell banking with 21CFR capability.● Responsible for feedback to OEM for equipment design improvement, system logic development/revisions. ● As part of technology implementation, my role is to evaluate novel technologies for implementation in manufacturing processes while ensuring all the regulatory requirements as per US-FDA, EU, GAMP5 are met.

Pune Area, India

● Subject matter expertise in manufacturing process technologies. ● Envisioned, designed and deployed innovative, fully customized automated virus inactivation system critical for realization of fully continuous bioprocess for monoclonal antibody manufacturing. Conceptualized and engineered control software, hardware and human machine interface. Patent applied. ● Evaluated Cartistem drug technology for Indian market. Conducted overall assessment of the technology feasibility and limitations. Recommended course of action to management based on the technology evaluation. ● Evaluated Raman Spectroscopy for in line process monitoring and to establish process analytical technology (PAT) in continuous bioprocess. Performed cost benefit analysis of the technology.● Evaluated SoloVPE spectrometer for implementation in manufacturing floor just in time analytics. ● Evaluated & implementation of advanced robotic platforms for laboratory automation ● Training and mentoring interns for their thesis project. Interns secured positions in IIT and IISC.

Pune, Maharashtra, India

● Clone development- Part of team which established genetically engineered high expression bacterial and mammalian clones for commercial scale protein manufacturing for biosimilar products.● Subject matter expertise in microbial and mammalian recombinant DNA clone development, cell culturing techniques and molecular biology techniques. Developed strategy for high expression DNA vectors.

Basel Area, Switzerland

Molecular and Developmental Characterization of Functions of the let-7 miRNA and its Target LIN-41 in Controlling Temporal Patterning in C. elegansThe aim of this project carried out at the Friedrich Miescher Institute was to understand how the two critical genes lethal-7 (let-7) miRNA and it’s down stream target lineage defective 41 (lin-41) function as post-transcriptional regulators of gene expression. Understanding the mechanism behind such regulation is important, since both these genes are implicated in the regulation of reprogramming of differentiated cells to induced pluripotent stem cells.

Greater Boston Area

Derivation and characterization of amniocyte-derived mouse and human induced pluripotent stem cells: The goal of this project carried out at Harvard Medical School was to test the ability to generate induced pluripotent stem cells from mouse and human amniocytes using retroviral vectors by introducing a specific cohort of embryonic stem cell genes.

Pune Area, India

Prior Art search for patents using various databases such as Micropatent, Delphion, Espacenet, USPTO, WIPO etc in the field of fermentation technologies. Patent Trend Analysis. Literature search and analysis- Science Direct, Pubmed, SciFinder, Taylor & Francis etc, in the field of fermentation technologies

Doctor Of Philosophy (Phd), Epigenetics

Master Of Science, Molecular Biology

Master Of Science, Bioinformatics

Bachelor Of Science, Microbiology