Sameer Kalghatgi, PhD
Director, Technical Operations at NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals- Claim this Profile
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Kannada Native or bilingual proficiency
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Marathi Native or bilingual proficiency
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Hindi Native or bilingual proficiency
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Gujarati Elementary proficiency
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English Full professional proficiency
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English Native or bilingual proficiency
Topline Score
Bio
Ken Rosenthal
As a consultant-collaborator, I had the opportunity to work with and observe Sameer Kalghatgi, PhD in his job capacity at EP Technologies and as such can provide my highest recommendation for him as a project and team leader or even as a team player. Sameer was in charge of a project that combined state of the art biophysical technology with molecular and cancer biology, specifically, the utilization of plasma to deliver macromolecules, including DNA, across the skin. These studies were the basis for establishing a new technology that greatly improves upon the methods for DNA vaccine delivery. DNA vaccines for humans are now in human trials. He was responsible for initiating, designing, directing and implementing the studies that translated concept into findings. This included internal project design, SBIR grant writing and submission, and internal reporting. As manager of the project and the team, Sammer effectively collaborated with internal and external resources and subject matter experts. Sameer was quick to understand, appreciate and apply new information, effective at identifying important questions and then detailing the experiments necessary to answer these questions. He is a hands-on manager who participated in the bench, animal and technical work. He is respectful and interested in the welfare of others and a good colleague and manager. He would be an asset to any company or team. Ken S. Rosenthal, Ph.D., Professor of Biomedical Sciences and Director of Microbiology and Immunology, Roseman University of Health Sciences College of Medicine; Professor Emeritus, Northeast Ohio Medical University.
Robert Geiger
Sameer is a great and intelligent guy. His knowledge is not strictly limited to his degree concentration of Electrical Engineering. He is capable of so much more. From working with the complex physics involved in plasma and even extending to the complexity of biological processes such as blood coagulation and cancer treatments, Sameer has certainly demonstrated that he can do it all.
Moogega Cooper
Sameer is an extremely hard-working student. We work on separate projects, however there were times in the past where collaborations were needed. Sameer had immense insight into the science behind the methods he was using as well as an understanding of his big-picture direction. His work ethic is strong and he will be an excellent candidate for all positions he applies himself to.
Ken Rosenthal
As a consultant-collaborator, I had the opportunity to work with and observe Sameer Kalghatgi, PhD in his job capacity at EP Technologies and as such can provide my highest recommendation for him as a project and team leader or even as a team player. Sameer was in charge of a project that combined state of the art biophysical technology with molecular and cancer biology, specifically, the utilization of plasma to deliver macromolecules, including DNA, across the skin. These studies were the basis for establishing a new technology that greatly improves upon the methods for DNA vaccine delivery. DNA vaccines for humans are now in human trials. He was responsible for initiating, designing, directing and implementing the studies that translated concept into findings. This included internal project design, SBIR grant writing and submission, and internal reporting. As manager of the project and the team, Sammer effectively collaborated with internal and external resources and subject matter experts. Sameer was quick to understand, appreciate and apply new information, effective at identifying important questions and then detailing the experiments necessary to answer these questions. He is a hands-on manager who participated in the bench, animal and technical work. He is respectful and interested in the welfare of others and a good colleague and manager. He would be an asset to any company or team. Ken S. Rosenthal, Ph.D., Professor of Biomedical Sciences and Director of Microbiology and Immunology, Roseman University of Health Sciences College of Medicine; Professor Emeritus, Northeast Ohio Medical University.
Robert Geiger
Sameer is a great and intelligent guy. His knowledge is not strictly limited to his degree concentration of Electrical Engineering. He is capable of so much more. From working with the complex physics involved in plasma and even extending to the complexity of biological processes such as blood coagulation and cancer treatments, Sameer has certainly demonstrated that he can do it all.
Moogega Cooper
Sameer is an extremely hard-working student. We work on separate projects, however there were times in the past where collaborations were needed. Sameer had immense insight into the science behind the methods he was using as well as an understanding of his big-picture direction. His work ethic is strong and he will be an excellent candidate for all positions he applies himself to.
Ken Rosenthal
As a consultant-collaborator, I had the opportunity to work with and observe Sameer Kalghatgi, PhD in his job capacity at EP Technologies and as such can provide my highest recommendation for him as a project and team leader or even as a team player. Sameer was in charge of a project that combined state of the art biophysical technology with molecular and cancer biology, specifically, the utilization of plasma to deliver macromolecules, including DNA, across the skin. These studies were the basis for establishing a new technology that greatly improves upon the methods for DNA vaccine delivery. DNA vaccines for humans are now in human trials. He was responsible for initiating, designing, directing and implementing the studies that translated concept into findings. This included internal project design, SBIR grant writing and submission, and internal reporting. As manager of the project and the team, Sammer effectively collaborated with internal and external resources and subject matter experts. Sameer was quick to understand, appreciate and apply new information, effective at identifying important questions and then detailing the experiments necessary to answer these questions. He is a hands-on manager who participated in the bench, animal and technical work. He is respectful and interested in the welfare of others and a good colleague and manager. He would be an asset to any company or team. Ken S. Rosenthal, Ph.D., Professor of Biomedical Sciences and Director of Microbiology and Immunology, Roseman University of Health Sciences College of Medicine; Professor Emeritus, Northeast Ohio Medical University.
Robert Geiger
Sameer is a great and intelligent guy. His knowledge is not strictly limited to his degree concentration of Electrical Engineering. He is capable of so much more. From working with the complex physics involved in plasma and even extending to the complexity of biological processes such as blood coagulation and cancer treatments, Sameer has certainly demonstrated that he can do it all.
Moogega Cooper
Sameer is an extremely hard-working student. We work on separate projects, however there were times in the past where collaborations were needed. Sameer had immense insight into the science behind the methods he was using as well as an understanding of his big-picture direction. His work ethic is strong and he will be an excellent candidate for all positions he applies himself to.
Ken Rosenthal
As a consultant-collaborator, I had the opportunity to work with and observe Sameer Kalghatgi, PhD in his job capacity at EP Technologies and as such can provide my highest recommendation for him as a project and team leader or even as a team player. Sameer was in charge of a project that combined state of the art biophysical technology with molecular and cancer biology, specifically, the utilization of plasma to deliver macromolecules, including DNA, across the skin. These studies were the basis for establishing a new technology that greatly improves upon the methods for DNA vaccine delivery. DNA vaccines for humans are now in human trials. He was responsible for initiating, designing, directing and implementing the studies that translated concept into findings. This included internal project design, SBIR grant writing and submission, and internal reporting. As manager of the project and the team, Sammer effectively collaborated with internal and external resources and subject matter experts. Sameer was quick to understand, appreciate and apply new information, effective at identifying important questions and then detailing the experiments necessary to answer these questions. He is a hands-on manager who participated in the bench, animal and technical work. He is respectful and interested in the welfare of others and a good colleague and manager. He would be an asset to any company or team. Ken S. Rosenthal, Ph.D., Professor of Biomedical Sciences and Director of Microbiology and Immunology, Roseman University of Health Sciences College of Medicine; Professor Emeritus, Northeast Ohio Medical University.
Robert Geiger
Sameer is a great and intelligent guy. His knowledge is not strictly limited to his degree concentration of Electrical Engineering. He is capable of so much more. From working with the complex physics involved in plasma and even extending to the complexity of biological processes such as blood coagulation and cancer treatments, Sameer has certainly demonstrated that he can do it all.
Moogega Cooper
Sameer is an extremely hard-working student. We work on separate projects, however there were times in the past where collaborations were needed. Sameer had immense insight into the science behind the methods he was using as well as an understanding of his big-picture direction. His work ethic is strong and he will be an excellent candidate for all positions he applies himself to.
Credentials
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Root Cause Analysis: Getting to the Root of Business Problems
LinkedInSep, 2023- Sep, 2024 -
Six Sigma: Green Belt
LinkedInAug, 2023- Sep, 2024 -
Improving Your Leadership Communications
LinkedInJan, 2023- Sep, 2024 -
Lean Six Sigma
National Association of State Boards of AccountancyJun, 2021- Sep, 2024 -
Management Development
SHRMJun, 2018- Sep, 2024 -
Making the transition from Staff to Supervisor
Fred Pryor Seminars and CareerTrackApr, 2015- Sep, 2024 -
Crash course for the first time manager
Fred Pryor Seminars and CareerTrackFeb, 2015- Sep, 2024 -
Fundamentals of Project Management
Fred Pryor Seminars and CareerTrackOct, 2014- Sep, 2024
Experience
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NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals
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United States
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Biotechnology
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1 - 100 Employee
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Director, Technical Operations
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Sep 2022 - Aug 2023
• Expanded team from 3 to 17 SMEs, while leading the development and commissioning of two 7,500 sq. ft., $15M cutting-edge end-to-end biomanufacturing plants within 9 months to produce viral vector products (200L) and biologics (up to 2,000L) in a cGMP setting • Delivered dedicated technical and leadership support, including comprehensive analytical testing capabilities, to a diverse client base encompassing 200+ biotech and biopharma companies • Managed an annual operating budget of $20M… Show more • Expanded team from 3 to 17 SMEs, while leading the development and commissioning of two 7,500 sq. ft., $15M cutting-edge end-to-end biomanufacturing plants within 9 months to produce viral vector products (200L) and biologics (up to 2,000L) in a cGMP setting • Delivered dedicated technical and leadership support, including comprehensive analytical testing capabilities, to a diverse client base encompassing 200+ biotech and biopharma companies • Managed an annual operating budget of $20M to support the needs of the company’s overall technical operations and strategic goals meeting or exceeding all budgetary objectives to enable the onboarding of new clients and offer state of the art mfg. facilities. • Built a $10M 200L cGMP plant and optimized access to and increased the utility of viral vectors for novel cell and gene-based therapeutics through the introduction of 200L scale cGMP platform processes, assays, and testing modalities for AAV/LV products • Spearheaded the construction of a $5M, state-of-the-art Center of Excellence for biomanufacturing analytics, championing product characterization, and identity, potency, and purity testing via development of robust assays under ICHQ2 (R2) and FDA guidelines • Onboarded a new quality management system (QMS) and laboratory information management system (LIMS) • Provided expert leadership and strong technical input related to laboratories and manufacturing test beds, leveraging hands-on expertise in MSAT including the revitalization of existing R&D pace and designing advanced cGMP space to onboard 50 new clients Show less • Expanded team from 3 to 17 SMEs, while leading the development and commissioning of two 7,500 sq. ft., $15M cutting-edge end-to-end biomanufacturing plants within 9 months to produce viral vector products (200L) and biologics (up to 2,000L) in a cGMP setting • Delivered dedicated technical and leadership support, including comprehensive analytical testing capabilities, to a diverse client base encompassing 200+ biotech and biopharma companies • Managed an annual operating budget of $20M… Show more • Expanded team from 3 to 17 SMEs, while leading the development and commissioning of two 7,500 sq. ft., $15M cutting-edge end-to-end biomanufacturing plants within 9 months to produce viral vector products (200L) and biologics (up to 2,000L) in a cGMP setting • Delivered dedicated technical and leadership support, including comprehensive analytical testing capabilities, to a diverse client base encompassing 200+ biotech and biopharma companies • Managed an annual operating budget of $20M to support the needs of the company’s overall technical operations and strategic goals meeting or exceeding all budgetary objectives to enable the onboarding of new clients and offer state of the art mfg. facilities. • Built a $10M 200L cGMP plant and optimized access to and increased the utility of viral vectors for novel cell and gene-based therapeutics through the introduction of 200L scale cGMP platform processes, assays, and testing modalities for AAV/LV products • Spearheaded the construction of a $5M, state-of-the-art Center of Excellence for biomanufacturing analytics, championing product characterization, and identity, potency, and purity testing via development of robust assays under ICHQ2 (R2) and FDA guidelines • Onboarded a new quality management system (QMS) and laboratory information management system (LIMS) • Provided expert leadership and strong technical input related to laboratories and manufacturing test beds, leveraging hands-on expertise in MSAT including the revitalization of existing R&D pace and designing advanced cGMP space to onboard 50 new clients Show less
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WuXi Advanced Therapies
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United States
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Biotechnology Research
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200 - 300 Employee
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Director, Molecular Biology (Testing, AD, and QA)
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Jul 2021 - Sep 2022
• Steered a cGMP testing lab, supporting 250+ clients, growing the team by 30%, from 33 to 51 employees, and accelerating monthly revenue from $850K to $1.6M to expand yearly revenue from $15M to $20M while sustaining profitability for 3 consecutive quarters • Leveraged Six Sigma, Lean, and Agile methodologies to amplify sample testing capacity by 87.5%, from 800 per month to 1,500 per month, and decrease average turnaround time from 21 to 14 days utilizing STAT testing of 5 days turnaround… Show more • Steered a cGMP testing lab, supporting 250+ clients, growing the team by 30%, from 33 to 51 employees, and accelerating monthly revenue from $850K to $1.6M to expand yearly revenue from $15M to $20M while sustaining profitability for 3 consecutive quarters • Leveraged Six Sigma, Lean, and Agile methodologies to amplify sample testing capacity by 87.5%, from 800 per month to 1,500 per month, and decrease average turnaround time from 21 to 14 days utilizing STAT testing of 5 days turnaround time for urgent samples. Provided technical expertise across various molecular assays including qPCR, ddPCR, ELISA, RCL/RCA, and residual • Successfully led the team in the delivery of essential testing services to 200+ clients across the biotech and biopharma industry, utilizing robust client management and client engagement skills to ensure high quality, satisfaction, 99% right first time, and retention • Played a pivotal role in the transfer of 50+ assays to a new 165k sq. ft. space while supporting extensive qualification work & audits • Reduced open compliance items (deviations and CAPAs) in collaboration with internal and client QA by 93% from 59 to 4 in 6 mo. • Ensures testing is scheduled and performed. Provide strong in-house guidance on science and technology • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.Responsible for appropriately conducting assays in accordance with GLPs or cGMPs. • Oversee the preparation and revision of technical documents (Client Protocols, SOPs, etc.) • Works with Client Delivery and clients to ensure the appropriate testing methodology is applied • Collaborates with other Testing Operations teams and PHL site teams to ensure project timelines are met. Show less • Steered a cGMP testing lab, supporting 250+ clients, growing the team by 30%, from 33 to 51 employees, and accelerating monthly revenue from $850K to $1.6M to expand yearly revenue from $15M to $20M while sustaining profitability for 3 consecutive quarters • Leveraged Six Sigma, Lean, and Agile methodologies to amplify sample testing capacity by 87.5%, from 800 per month to 1,500 per month, and decrease average turnaround time from 21 to 14 days utilizing STAT testing of 5 days turnaround… Show more • Steered a cGMP testing lab, supporting 250+ clients, growing the team by 30%, from 33 to 51 employees, and accelerating monthly revenue from $850K to $1.6M to expand yearly revenue from $15M to $20M while sustaining profitability for 3 consecutive quarters • Leveraged Six Sigma, Lean, and Agile methodologies to amplify sample testing capacity by 87.5%, from 800 per month to 1,500 per month, and decrease average turnaround time from 21 to 14 days utilizing STAT testing of 5 days turnaround time for urgent samples. Provided technical expertise across various molecular assays including qPCR, ddPCR, ELISA, RCL/RCA, and residual • Successfully led the team in the delivery of essential testing services to 200+ clients across the biotech and biopharma industry, utilizing robust client management and client engagement skills to ensure high quality, satisfaction, 99% right first time, and retention • Played a pivotal role in the transfer of 50+ assays to a new 165k sq. ft. space while supporting extensive qualification work & audits • Reduced open compliance items (deviations and CAPAs) in collaboration with internal and client QA by 93% from 59 to 4 in 6 mo. • Ensures testing is scheduled and performed. Provide strong in-house guidance on science and technology • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.Responsible for appropriately conducting assays in accordance with GLPs or cGMPs. • Oversee the preparation and revision of technical documents (Client Protocols, SOPs, etc.) • Works with Client Delivery and clients to ensure the appropriate testing methodology is applied • Collaborates with other Testing Operations teams and PHL site teams to ensure project timelines are met. Show less
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Infinity BiologiX
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United States
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Biotechnology Research
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1 - 100 Employee
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Sr. Director, Laboratory Operations
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Oct 2020 - Jun 2021
• Secured a $15.5M contract from the CDC to sequence 3K-6K COVID saliva samples each week for strain and lineage determination, hiring 12 FTEs and commissioning a myriad of library prep robots and sequencers to enable the fulfillment of contract obligations • Achieved a record-breaking $250M in revenue in 9 months at the peak of the COVID-19 Pandemic, building a 60K sq. ft. fully automated NAT/CLIA testing COVID laboratory operated by 225 employees who processed and analyzed 15K-20K samples… Show more • Secured a $15.5M contract from the CDC to sequence 3K-6K COVID saliva samples each week for strain and lineage determination, hiring 12 FTEs and commissioning a myriad of library prep robots and sequencers to enable the fulfillment of contract obligations • Achieved a record-breaking $250M in revenue in 9 months at the peak of the COVID-19 Pandemic, building a 60K sq. ft. fully automated NAT/CLIA testing COVID laboratory operated by 225 employees who processed and analyzed 15K-20K samples per day • Reduced cost from $27 to $16 per sample by utilizing high-throughput automation, increasing per day capacity from 3,500 samples to 50,000 samples, contributing to a 600% revenue gain, growing from $500K to $3.5M revenue per day Show less • Secured a $15.5M contract from the CDC to sequence 3K-6K COVID saliva samples each week for strain and lineage determination, hiring 12 FTEs and commissioning a myriad of library prep robots and sequencers to enable the fulfillment of contract obligations • Achieved a record-breaking $250M in revenue in 9 months at the peak of the COVID-19 Pandemic, building a 60K sq. ft. fully automated NAT/CLIA testing COVID laboratory operated by 225 employees who processed and analyzed 15K-20K samples… Show more • Secured a $15.5M contract from the CDC to sequence 3K-6K COVID saliva samples each week for strain and lineage determination, hiring 12 FTEs and commissioning a myriad of library prep robots and sequencers to enable the fulfillment of contract obligations • Achieved a record-breaking $250M in revenue in 9 months at the peak of the COVID-19 Pandemic, building a 60K sq. ft. fully automated NAT/CLIA testing COVID laboratory operated by 225 employees who processed and analyzed 15K-20K samples per day • Reduced cost from $27 to $16 per sample by utilizing high-throughput automation, increasing per day capacity from 3,500 samples to 50,000 samples, contributing to a 600% revenue gain, growing from $500K to $3.5M revenue per day Show less
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Coriell Institute for Medical Research
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United States
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Research
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1 - 100 Employee
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Director, Laboratory Operations
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Jan 2019 - Oct 2020
• Promoted from Assistant Director to Director within 1.5 years, charged with leading 4 laboratories, Cell Culture, Molecular Biology, Stem Cell, and Cytogenetics, and 32 employees, boosting revenue from $17M to $20M annually through cost savings, lean operations, operational excellence, automated processing, strategic resource planning/optimization, and product line expansion • Introduced lab automation to increase capacity and efficiency, support the creation of new products, including… Show more • Promoted from Assistant Director to Director within 1.5 years, charged with leading 4 laboratories, Cell Culture, Molecular Biology, Stem Cell, and Cytogenetics, and 32 employees, boosting revenue from $17M to $20M annually through cost savings, lean operations, operational excellence, automated processing, strategic resource planning/optimization, and product line expansion • Introduced lab automation to increase capacity and efficiency, support the creation of new products, including iPSCs derived from patient samples, distributed to organizations in 83+ countries to benefit their research efforts for developing novel therapeutics • Partnered with rare disease foundations to provide custom iPSC generation and characterization to yield $2M in additional revenue • Championed hyper-growth, elevating lab operations by 50-200% to achieve $1.8M in additional revenue, building a new iPSC team to offer specialized services and produce an impressive $700K in revenue, and managing multi-million-dollar contracts and projects for NIH, disease foundations, academic partners, and commercial clients to generate a gross revenue of $17M annually
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Assistant Director, Laboratory Operations
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Jun 2018 - Jan 2019
• Reporting to the Director, Laboratory Operations, responsible for the day-to-day oversight & operations of four major labs. • Worked closely with rare disease foundations to offer iPSC generation & characterization services leading to new revenue. • Directly responsible for increasing lab operations across 4 labs by 50 – 200% resulting in generation of $1.8M in new revenue. • Mentor, motivate, and directly supervise a team of 30 including technicians, team leads and lab managers… Show more • Reporting to the Director, Laboratory Operations, responsible for the day-to-day oversight & operations of four major labs. • Worked closely with rare disease foundations to offer iPSC generation & characterization services leading to new revenue. • Directly responsible for increasing lab operations across 4 labs by 50 – 200% resulting in generation of $1.8M in new revenue. • Mentor, motivate, and directly supervise a team of 30 including technicians, team leads and lab managers across Cell Culture, Molecular Biology Laboratory, Stem Cell and Cytogenomics laboratories, providing scientific and technical expertise. • Part of core group responsible for triaging new business opportunities. Generated new business worth $1.5M since Jan 2018.
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Assistant Director, Cell and Molecular Biology Laboratories
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May 2017 - Jun 2018
⋅ Reporting to the Director of Laboratory Operations, I lead four major laboratory teams in providing cell culture, stem cell and molecular biology services for a large number of diverse customers and clients including NIH, pharmaceutical organizations and major biotech companies. ⋅ Lead a large team of 30+ technicians and managers across the cell culture, molecular biology, stem cell and cytogenomics lab in the direction of daily workflow to meet all production and contract deliverables and… Show more ⋅ Reporting to the Director of Laboratory Operations, I lead four major laboratory teams in providing cell culture, stem cell and molecular biology services for a large number of diverse customers and clients including NIH, pharmaceutical organizations and major biotech companies. ⋅ Lead a large team of 30+ technicians and managers across the cell culture, molecular biology, stem cell and cytogenomics lab in the direction of daily workflow to meet all production and contract deliverables and streamline laboratory processes. Provide scientific and technical oversight. ⋅ Develop, review, implement, and optimize SOPs and lead troubleshooting efforts. ⋅ Explore and on board new automation technologies and industry-accepted processes. ⋅ Effectively work with the IT application development team and other internal departments to improve our information management software and better integrate bio specimen data. ⋅ Review, analyze, and report on cell culture, stem cell, molecular biology and cytogenomics data ⋅ Provide regular updates to the Biobanking Team and company leadership on cell culture, molecular biology, stem cell and cytogenomics lab processes and activities. ⋅ Provide critical inputs to executive leadership related to new business, current status, resourcing, hiring, people management, capacity, current and future pipeline, automation and instrumentation, process improvements, new services, costing, production and quality metrics and overall health of the laboratory operations ⋅ Represent Coriell at numerous conferences related to biobanking, stem cell, molecular biology, cell culture, etc. ⋅ Volunteer and participate in numerous Coriell organized events including annual science fairs, summer experience program and other community outreach activities
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EP Technologies LLC
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United States
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Biotechnology Research
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Senior Scientist
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Feb 2013 - Mar 2017
• Awarded 7 patents related to the development of plasma as a novel medical device for drug delivery and surface decontamination • As a founding employee, achieved increased investment in EPT from $1M to $8M, a 700% improvement across 3 years, by developing novel plasma applications, capturing early IP, hiring and onboarding employees, and driving 2 key development projects designed to advance the technical feasibility and commercial viability of topical drug delivery and DNA vaccination… Show more • Awarded 7 patents related to the development of plasma as a novel medical device for drug delivery and surface decontamination • As a founding employee, achieved increased investment in EPT from $1M to $8M, a 700% improvement across 3 years, by developing novel plasma applications, capturing early IP, hiring and onboarding employees, and driving 2 key development projects designed to advance the technical feasibility and commercial viability of topical drug delivery and DNA vaccination utilizing plasma • Joined forces with established biotechnology companies, overseeing product development efforts for the use of non-thermal plasma as a sterilizing device and as a transdermal drug delivery system, accomplishing 2 milestone payments of $200K each • Employed biomedical engineering expertise, pioneering the use of cold plasma for transdermal delivery of large macromolecules-like mAbs and DNA plasmids, demonstrated the first ever application of plasma to drive vaccines transdermally into immune cells • Sr. Scientist and one of the founding employee responsible for increasing investment, developing clinical applications of non-thermal plasma, building a world-class team, and driving major projects that proved the safety and feasibility of non-thermal plasma for a variety of biomedical applications. • Led a multi-disciplinary team consisting of technical, commercial & regulatory members to design, plan, and execute preclinical studies. • Significant contributor to EPT's extensive patent portfolio development including as First inventor. • Awarded 3 US patent for elimination of hospital-acquired C. difficile bacterium infections using cold electrical plasma. • Well versed in the FDA regulatory processes: IND, PMA, 510(k), cGLP, cGMP, ISO10993-1, 21CFR58, & 21CFR10.115(b). • Enrolled EPT as a first client of industry-academia incubator at a local university. • Technical liaison between external regulatory consultants and EPT management. Show less • Awarded 7 patents related to the development of plasma as a novel medical device for drug delivery and surface decontamination • As a founding employee, achieved increased investment in EPT from $1M to $8M, a 700% improvement across 3 years, by developing novel plasma applications, capturing early IP, hiring and onboarding employees, and driving 2 key development projects designed to advance the technical feasibility and commercial viability of topical drug delivery and DNA vaccination… Show more • Awarded 7 patents related to the development of plasma as a novel medical device for drug delivery and surface decontamination • As a founding employee, achieved increased investment in EPT from $1M to $8M, a 700% improvement across 3 years, by developing novel plasma applications, capturing early IP, hiring and onboarding employees, and driving 2 key development projects designed to advance the technical feasibility and commercial viability of topical drug delivery and DNA vaccination utilizing plasma • Joined forces with established biotechnology companies, overseeing product development efforts for the use of non-thermal plasma as a sterilizing device and as a transdermal drug delivery system, accomplishing 2 milestone payments of $200K each • Employed biomedical engineering expertise, pioneering the use of cold plasma for transdermal delivery of large macromolecules-like mAbs and DNA plasmids, demonstrated the first ever application of plasma to drive vaccines transdermally into immune cells • Sr. Scientist and one of the founding employee responsible for increasing investment, developing clinical applications of non-thermal plasma, building a world-class team, and driving major projects that proved the safety and feasibility of non-thermal plasma for a variety of biomedical applications. • Led a multi-disciplinary team consisting of technical, commercial & regulatory members to design, plan, and execute preclinical studies. • Significant contributor to EPT's extensive patent portfolio development including as First inventor. • Awarded 3 US patent for elimination of hospital-acquired C. difficile bacterium infections using cold electrical plasma. • Well versed in the FDA regulatory processes: IND, PMA, 510(k), cGLP, cGMP, ISO10993-1, 21CFR58, & 21CFR10.115(b). • Enrolled EPT as a first client of industry-academia incubator at a local university. • Technical liaison between external regulatory consultants and EPT management. Show less
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Boston University
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United States
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Higher Education
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700 & Above Employee
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Post Doctoral Research Fellow
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Apr 2010 - Jan 2013
Performed lab-based studies under advisor J. J. Collins and conducted cell culture experiments and gene expression analysis to evaluate the effects of antibiotics in systems biology, mammalian tissue culture, molecular biology, biochemistry and murine models. • Setup a tissue culture and molecular biology lab to successfully lead a project on investigating the deleterious effects of antibiotics on human cells using an integrated cellular biology - systems biology approach. • Studied… Show more Performed lab-based studies under advisor J. J. Collins and conducted cell culture experiments and gene expression analysis to evaluate the effects of antibiotics in systems biology, mammalian tissue culture, molecular biology, biochemistry and murine models. • Setup a tissue culture and molecular biology lab to successfully lead a project on investigating the deleterious effects of antibiotics on human cells using an integrated cellular biology - systems biology approach. • Studied mitochondrial morphogenesis and demonstrated that the antibiotics impair clearance of aging mitochondria. • Pioneered the investigation of the underlying biological mechanisms of action of long term use of antibiotics on mammalian cells, using targeted sequencing via NGS library prep for studying DNA damage, oxidative stress, mitochondrial morphogenesis, up/down regulation of key genes. • Prepared samples from tumors, cell culture and blood for whole genome & whole transcriptome sequencing to evaluate effects of antibiotics on human cells • Published cutting-edge genome level study of antibiotic induced changes in transcription “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Stress in Mammalian Cells.” (Published in Science Translational Medicine). • Experienced in running and maintaining a multi-color BD LSRFortessa flow cytometer and Seahorse metabolic analyzer. Show less Performed lab-based studies under advisor J. J. Collins and conducted cell culture experiments and gene expression analysis to evaluate the effects of antibiotics in systems biology, mammalian tissue culture, molecular biology, biochemistry and murine models. • Setup a tissue culture and molecular biology lab to successfully lead a project on investigating the deleterious effects of antibiotics on human cells using an integrated cellular biology - systems biology approach. • Studied… Show more Performed lab-based studies under advisor J. J. Collins and conducted cell culture experiments and gene expression analysis to evaluate the effects of antibiotics in systems biology, mammalian tissue culture, molecular biology, biochemistry and murine models. • Setup a tissue culture and molecular biology lab to successfully lead a project on investigating the deleterious effects of antibiotics on human cells using an integrated cellular biology - systems biology approach. • Studied mitochondrial morphogenesis and demonstrated that the antibiotics impair clearance of aging mitochondria. • Pioneered the investigation of the underlying biological mechanisms of action of long term use of antibiotics on mammalian cells, using targeted sequencing via NGS library prep for studying DNA damage, oxidative stress, mitochondrial morphogenesis, up/down regulation of key genes. • Prepared samples from tumors, cell culture and blood for whole genome & whole transcriptome sequencing to evaluate effects of antibiotics on human cells • Published cutting-edge genome level study of antibiotic induced changes in transcription “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Stress in Mammalian Cells.” (Published in Science Translational Medicine). • Experienced in running and maintaining a multi-color BD LSRFortessa flow cytometer and Seahorse metabolic analyzer. Show less
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Drexel University
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United States
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Higher Education
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700 & Above Employee
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PhD Candidate and Research Fellow
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Sep 2004 - Mar 2010
Pioneered critical investigations of biophysical mechanisms of interaction of non-thermal plasma, a novel medical device, with human cells. Became experienced in cell culture, cell handling and adapting CHO cells to grow in bench-scale fed-batch and single use perfusion bioreactors. Developed a strong background in bioreactor engineering, operation, troubleshooting and optimization. Applied RNAi and advanced molecular biology techniques. • Awarded US patent for and published novel… Show more Pioneered critical investigations of biophysical mechanisms of interaction of non-thermal plasma, a novel medical device, with human cells. Became experienced in cell culture, cell handling and adapting CHO cells to grow in bench-scale fed-batch and single use perfusion bioreactors. Developed a strong background in bioreactor engineering, operation, troubleshooting and optimization. Applied RNAi and advanced molecular biology techniques. • Awarded US patent for and published novel discoveries in plasma-induced proliferation in endothelial cells as a potential therapy for treating diseases with poor or abnormal vascularization. (Published in ABME). • Successfully completed and published the study of DNA repair pathways in response to damage induced by oxidative stress due to non-thermal plasma treatment of mammalian cells and tissue for the first time. (Published in PLOS One). • Conducted molecular biology assays and led whole genome sequencing and targeted sequencing assays using NGS library prep to evaluate the effects of oxidative stress induced by electrical plasma treatment on mammalian cells. • Revived and led a struggling project to conduct successful investigation of the biological mechanisms of selective apoptosis induced in melanoma cells by non-thermal plasma to develop plasma as a novel device for cancer therapy. • Published discoveries of non-thermal plasma for blood coagulation. (Published in IEEE Trans. on Plasma Science). Adapted CHO cells to grow in laboratory-scale fed-batch and single use perfusion bioreactors. • Adept at lentivirus production using shRNA to transfect 293T cells with VSVG, RRE and RSV-Rev packaging vectors to generate corresponding pseudoviruses to transfect mammalian cells for generation of ATM-/- or ATR-/- cell lines. Show less Pioneered critical investigations of biophysical mechanisms of interaction of non-thermal plasma, a novel medical device, with human cells. Became experienced in cell culture, cell handling and adapting CHO cells to grow in bench-scale fed-batch and single use perfusion bioreactors. Developed a strong background in bioreactor engineering, operation, troubleshooting and optimization. Applied RNAi and advanced molecular biology techniques. • Awarded US patent for and published novel… Show more Pioneered critical investigations of biophysical mechanisms of interaction of non-thermal plasma, a novel medical device, with human cells. Became experienced in cell culture, cell handling and adapting CHO cells to grow in bench-scale fed-batch and single use perfusion bioreactors. Developed a strong background in bioreactor engineering, operation, troubleshooting and optimization. Applied RNAi and advanced molecular biology techniques. • Awarded US patent for and published novel discoveries in plasma-induced proliferation in endothelial cells as a potential therapy for treating diseases with poor or abnormal vascularization. (Published in ABME). • Successfully completed and published the study of DNA repair pathways in response to damage induced by oxidative stress due to non-thermal plasma treatment of mammalian cells and tissue for the first time. (Published in PLOS One). • Conducted molecular biology assays and led whole genome sequencing and targeted sequencing assays using NGS library prep to evaluate the effects of oxidative stress induced by electrical plasma treatment on mammalian cells. • Revived and led a struggling project to conduct successful investigation of the biological mechanisms of selective apoptosis induced in melanoma cells by non-thermal plasma to develop plasma as a novel device for cancer therapy. • Published discoveries of non-thermal plasma for blood coagulation. (Published in IEEE Trans. on Plasma Science). Adapted CHO cells to grow in laboratory-scale fed-batch and single use perfusion bioreactors. • Adept at lentivirus production using shRNA to transfect 293T cells with VSVG, RRE and RSV-Rev packaging vectors to generate corresponding pseudoviruses to transfect mammalian cells for generation of ATM-/- or ATR-/- cell lines. Show less
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Education
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2004 - 2010
Drexel University
PhD, Electrical Engineering, Applications of Non-Thermal Plasma in Medicine -
1999 - 2003
Veermata Jijabai Technological Institute
BE, Engineering
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