Experience

CCRM

• Biotechnology Research
• 100 - 200 Employee

• Director, Manufacturing Science and Technology (MSAT)

  • Sep 2021 - Present

  Toronto, Ontario, Canada MSAT leader with a proven track record in leading cell and gene therapy CDMO management, technology transfer and GMP manufacturing. 15 plus years of Biopharmaceutical manufacturing and clinical development experience with extensive technical and strategic leadership for end-to-end manufacturing for early phase to commercial-scale manufacturing. I excel at innovation and implementing cutting-edge tools that transform organizational performances. Biopharmaceutical & bioprocess optimization &… Show more MSAT leader with a proven track record in leading cell and gene therapy CDMO management, technology transfer and GMP manufacturing. 15 plus years of Biopharmaceutical manufacturing and clinical development experience with extensive technical and strategic leadership for end-to-end manufacturing for early phase to commercial-scale manufacturing. I excel at innovation and implementing cutting-edge tools that transform organizational performances. Biopharmaceutical & bioprocess optimization & Feasibility | Tech design, scale-up & transfer GMP manufacturing | Leading, coaching, training & mentoring | Business development | Project management

• Senior Manager, Manufacturing Science and Technology (MSAT), and Manufacturing Operations

  • Nov 2019 - Sep 2021

  Toronto, Canada Area • Oversee Cell and Gene Therapy GMP technical operations and MSAT activities such as Seamless Scale-Up and Technology Transfer, process improvement, validation manufacturing support, and scale-up production at the Centre for Cell and Vector Production (CCVP). • Lead a team of MSAT scientists and manufacturing Associates highly focussed on GMP contract manufacturing of cell and gene therapy products for a fee for service regenerative medicine clients. Biopharmaceutical &… Show more • Oversee Cell and Gene Therapy GMP technical operations and MSAT activities such as Seamless Scale-Up and Technology Transfer, process improvement, validation manufacturing support, and scale-up production at the Centre for Cell and Vector Production (CCVP). • Lead a team of MSAT scientists and manufacturing Associates highly focussed on GMP contract manufacturing of cell and gene therapy products for a fee for service regenerative medicine clients. Biopharmaceutical & bioprocess optimisation & Feasibility | Tech design, scale-up & transfer GMP manufacturing | Leading, coaching, training & mentoring | Business development | Project management

• Operations Manager, GMP Contract Manufacturing, Centre for Cell and Vector Production

  • Jun 2018 - Nov 2019

  Toronto, Canada Area CDMO involved in GMP manufacturing of Cell and Gene Therapy product to support Phase I and Phase II in human clinical trials for regenerative medicine clients and the services includes: • Master and working cell banking • Induced pluripotent stem cells (iPSC) reprogramming • Small-scale autologous and large-scale allogeneic batches • Engineered T cell products /Immuno-oncology products • Fill & finish of drug substance and drug products • Scalable workflows • Complex and… Show more CDMO involved in GMP manufacturing of Cell and Gene Therapy product to support Phase I and Phase II in human clinical trials for regenerative medicine clients and the services includes: • Master and working cell banking • Induced pluripotent stem cells (iPSC) reprogramming • Small-scale autologous and large-scale allogeneic batches • Engineered T cell products /Immuno-oncology products • Fill & finish of drug substance and drug products • Scalable workflows • Complex and highly customized manufacturing batches



StemRx BioScience Solutions - India

• Principal Consultant, Cell Therapy Contract Manufacturing Operations

  • Jan 2018 - Jun 2018

  Mumbai Area, India • Cell therapy products manufacturing for Phase 1 and 2 Clinical Trials. Speciality area: Cardiovascular and Orthopedic indications. • Master Cell Bank (MCB) and Working Cell Bank (WCB) of Mesenchymal Stem Cells. • Contract Manufacturing of Cell Therapy Products for the “fee for service” clients • Regulatory submissions for manufacturing drug licenses (i.e. Human Mesenchymal stem cells derived from cord tissue, bone marrow and platelet lysate).



Cesca Therapeutics Inc.

• Senior Director, GMP Cell Processing Facility and Clinical Development

  • Feb 2013 - Dec 2017

  Sacramento, California Area Led GMP Manufacturing facility and Clinical development division involved in cell-based therapies for early phase clinical trials, commercial scale and biobanking. GMP Manufacturing: • Instrumental in setting up “Center for Excellence in Cellular Medicine” GMP facility involved in design, infrastructure, validations and regulatory licensing and GMP/GTP, GLP, GCP accreditation & US FDA registration • Process optimization and validation, manufacturing of cell-based therapies for… Show more Led GMP Manufacturing facility and Clinical development division involved in cell-based therapies for early phase clinical trials, commercial scale and biobanking. GMP Manufacturing: • Instrumental in setting up “Center for Excellence in Cellular Medicine” GMP facility involved in design, infrastructure, validations and regulatory licensing and GMP/GTP, GLP, GCP accreditation & US FDA registration • Process optimization and validation, manufacturing of cell-based therapies for early phase clinical trials focussed on Cardiovascular, Orthopedic, Neurology and hemato-oncology indications • Processing of >220 bone marrow or mobilized peripheral blood stem cell products for treating adult & pediatric hemato-oncology patients; Haploidentical T and B cell depletion processing; CD34+ve enrichment and NK cell selection processing. • Cord blood bank >4000 Umbilical cord blood processed, testing, storage, distribution and release. Clinical Development: • Clinical study designing, establishing the proof of concept, validation, and preparation of clinical study protocol, implementation and execution of the clinical studies, regulatory submissions. • Actively led in the design and execution of 6 cell therapy clinical trial protocols for Cardiovascular, Orthopedics, Neurological, and Hematology indications; clinical study data published in peer-reviewed journals. • Protocol steering committee member; involved in the study design and clinical trial protocol preparation of the cardiovascular study that received Investigational device exemption (IDE) approval or phase 3 pivotal study by US FDA Show less



TotipotentRX Cell Therapy Pvt. Ltd.

• Director, GMP Cell Processing Facility and Clinical Research Affairs

  • Feb 2011 - Feb 2013

  Fortis-totipotentRx center for cellular medicine, Fortis hospital, Gurgaon GMP Manufacturing Operations: Cell Processing facility director and cord blood bank Director at Fortis-TotipotentRX Centre for Cellular Medicine at Fortis Memorial Research Institute| Cell therapy manufacturing for early phase clinical trials and Blood/Marrow Transplant Program | Supervision GMP lab Operations | Responsible for oversight, coordination, and supervision of personnel and manufacturing activities related to the preparation and testing of cell based products that are utilized… Show more GMP Manufacturing Operations: Cell Processing facility director and cord blood bank Director at Fortis-TotipotentRX Centre for Cellular Medicine at Fortis Memorial Research Institute| Cell therapy manufacturing for early phase clinical trials and Blood/Marrow Transplant Program | Supervision GMP lab Operations | Responsible for oversight, coordination, and supervision of personnel and manufacturing activities related to the preparation and testing of cell based products that are utilized in clinical and research protocols | Regulator licensing, CMC submissions, Accreditation and audits Clinical Development: Responsible for clinical trial strategies and management of all the clinical studies | Clinical trial protocol Design and Development | IRB and regulatory submissions| Clinical trial Management- Site feasibility, selection, execution, AE/SAE Management, interim analyses and TLF and Clinical study report. Show less



TotipotentSC

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director Of Technical Operations

  • May 2009 - Feb 2011

  Gurgaon, India TotipotentSC is a stem cell technology driven organizations involved in the development, supply and consulting of cell-based therapies, innovative cell biology/stem cell biology tools and devices for processing and banking of cellular products to stem cell and cord blood banks . Optimize Clinical protocols using rapid point of care technologies| Orthopedic and vascular indications | Maintain ISO 13485 medical device manufacturing| GMP Facility operations| Validation and verification… Show more TotipotentSC is a stem cell technology driven organizations involved in the development, supply and consulting of cell-based therapies, innovative cell biology/stem cell biology tools and devices for processing and banking of cellular products to stem cell and cord blood banks . Optimize Clinical protocols using rapid point of care technologies| Orthopedic and vascular indications | Maintain ISO 13485 medical device manufacturing| GMP Facility operations| Validation and verification process of the medical devices | Developing and executing business strategic plans | Optimize and expand medical device business, and to promote revenue, profitability and efficiency.

• Assistant Director, Technical Operations

  • Apr 2009 - Mar 2010

  Gurgaon, Haryana, India Design, development and validation of cell therapy products (Medical Devices) for cord blood banking and Cell therapy.



TOTIPOTENTSC SCIENTIFIC PRODUCT PRIVATE LIMITED

• India
• Hospitals and Health Care

• Development Scientist /Scientific Manager

  • Sep 2008 - Feb 2009

  Chennai, Tamil Nadu, India Scientific validation of Medical devices for cord blood and stem cell Research. Technical support to the clients (Cord blood banks, Hospitals and Research Centers).



University of Illinois Chicago

• United States
• Higher Education
• 700 & Above Employee

• Post-Doctoral Scientist (Immunology)

  • Apr 2006 - Aug 2008

  Chicago, Illinois Immunology of Inflammation, studied the role of specific cytokines produced by adipocytes in inflammatory bowel disease (IBD), Crohn's and Ulcerative Colitis. Specifically focusing on identifying the role of leptin and adiponectin in stricture development in Crohn's disease. Studied the role of Adiponectin deficiency in radiation induced GI and hematopoietic damage.



Kamineni Academy of Medical Sciences and Research Centre

• India
• Hospitals and Health Care
• 1 - 100 Employee

• Asst. Professor of Microbiology

  • Oct 2000 - Mar 2002

  Hyderabad, Telangana, India Served as a Asst. Professor and Diagnostic Microbiologist at Kamineni Institute of Medical Sciences Hospital, Teaching Medical Graduate and Post-graduates.