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Cell Therapy manufacturing & technology leader with 20 years of global experience North America, Europe and Asia. Broad corporate experience in management across business, technical and operational disciplines/departments in the biotechnology and medical device field.
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Chief Executive OfficerOmniabio Jul 2022 - PresentHamilton, Ontario, Ca -
Board MemberStandards Coordinating Body (Scb) Apr 2022 - PresentGaithersburg, Md, Us -
Chief Operating OfficerCcrm Jun 2016 - Sep 2022Toronto, Ontario, CaLeadership of CCRM's C> CDMO from design through commercial operation. Lead business requirements including design and construction, development of a phase appropriate quality system (eQMS), operational systems (eBR), commercial services contracting/strategy, business development, digital marketing, manufacturing platform development and technology licensing (reprogramming, gene editing, LVV and autologous programs including CARs). With a current CDMO team growing to 150 this year, we are positioned for the next stage of complex biologic services in the C> space. To this end, I'm currently leading the development of a new 300,000 sq.ft. facility in the greater Toronto area.In addition to the CDMO, I'm also responsible for CCRM's overall operations, performance, budgeting and planning and have direct oversight of company creation, technology sourcing, and human resources. Operational reporting to the CEO & Board of Directors.About CCRM:CCRM is focused on solving the big problems in cell & gene therapy. Our collaborative approach is to create great companies, attract and provide venture capital, and support these specialized companies (and the industry) with leading-edge contract development and GMP manufacturing services. -
Senior Vice President, General Manager, Director Of International SubsidiariesCesca Therapeutics, Inc. Jan 2014 - Dec 2015Managed a global team (US, EU, India, China) involved in all aspects of development and commercialization of Cell Therapy processing equipment and companion disposables for therapeutic use in Intraoperative Orthopedics (Spine & Non-Unions) & Hematology/Oncology Markets (BMT, Cord Blood). Initiated Diagnostic Cell Enumeration Program.General Management:• Annual & Long Term Budgeting & Strategic Planning• Organizational Development, Operating Policies & Personnel ManagementCommercial Management:• Marketing, Sales, BD, Sales Operations & Technical Support. CRM implementation• Distribution & Direct Sales Management (B to B & B to C models)New Product Developent:• Design Engineering, Six-Sigma Product/Process Design, Scientific Development & Research• Clinical Trial Design• Development programs incl. concept, V&V, regulatory preparation and commercialization• Intraoperative Design Requirements ie. IEC 60601• Intellectual PropertyOperations Management:• Supply Chain, Manufacturing, Mfg Engineering, Logistics, IT and Facilities, ERP• In-house & Contract Manufacturing (US, Central America & Asia)Regulatory & Quality Management Reviews:• Global Regulatory Planning• Quality Reviews, Facility Certifications (GMP, ISO13485)About Cesca Therapeutics:Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. A leader in developing and manufacturing automated blood and bone marrow processing systems and companion disposable products that enable the separation, processing and preservation of cell and tissue therapy products.
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Co-Founder, Ceo & DirectorTotipotentrx (Mk Alliance, Inc.) 2007 - 2014TotipotentRX (MK Alliance, Inc.) was founded in Los Angeles. Major milestones achieved before acquisition by Thermogenesis Corp (became Cesca Therapeutics, Inc.) include:Medical Devices for Intraoperative Use:• Development of a rapid intraoperative medical device system for the treatment of critical limb ischemia having completed 8 pilot studies (clinical studies).• Completed a 3 year Ph1/2 clinical study with positive results (now finalizing preparation for Ph3 in the US & India).• Multi-year exclusive agreement as provider of stem cell technologies to Fortis Healthcare, India's second largest hospital group (70+ hospitals).• Designed, built, and licensed the first fully operational in-hospital cell manufacturing/biobanking facility in Asia.Medical Devices for Intralaboratory Use: • Design, construction and licensure of medical device manufacturing plant in India (GMP, ISO13485). • Implementation of all systems to commercialize an in-house developed tissue transport device. • Regulatory approval and commercialization of device technologies in Europe (CE) & India (DCGI).• Direct Sales success to largest BioBanks in India & Europe. Leading device in India.• Created successful medical device organization from scratch.About TotipotentRX (MK Alliance, Inc.):A cellular therapies development company, with particular emphasis in integrated point-of-care autologous therapies for cardio/vascular and orthopedic indications. The company merged with ThermoGenesis Corp on Feb 18, 2014 to form Cesca Therapeutics, Inc. [NASDAQ:KOOL]
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Global Program Manager, Medical Devices For Regenerative MedicinePall Corporation 2002 - 2007Port Washington, New York, UsSummary:• Management of Global Strategic Medical device initiatives for the Corp. RegenMed. Division• Technology assessment and business development for cord blood bio-banking market• Product development from concept through regulatory clearance in global markets• Finalized FDA clearance and global launch of first Cord Blood Collection bagAbout Pall Corporation:Recently acquired by Danaher Corporation. Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences, medicine and industry.
Mitchel Sivilotti Skills
Mitchel Sivilotti Education Details
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Queen'S UniversityMaster'S In Finance -
Western UniversityBiology - Genetics
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Université LavalCellular And Molecular Biology
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Western University
Frequently Asked Questions about Mitchel Sivilotti
What company does Mitchel Sivilotti work for?
Mitchel Sivilotti works for Omniabio
What is Mitchel Sivilotti's role at the current company?
Mitchel Sivilotti's current role is Chief Executive Officer at OmniaBio Inc..
What is Mitchel Sivilotti's email address?
Mitchel Sivilotti's email address is mi****@****tsc.com
What is Mitchel Sivilotti's direct phone number?
Mitchel Sivilotti's direct phone number is +141652*****
What schools did Mitchel Sivilotti attend?
Mitchel Sivilotti attended Queen's University, Western University, Université Laval, Western University.
What skills is Mitchel Sivilotti known for?
Mitchel Sivilotti has skills like Clinical Trials, Medical Devices, Cell Therapy, Clinical Research, R&d, Stem Cells, Immunology, Pharmaceutical Industry, Biotechnology, Cancer, Manufacturing, Cell Culture.
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