Rob Leone Email and Phone Number
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A pharmaceutical development professional with >20 years experience in the development of lipid nanoparticle (LNP) delivery systems and nucleic acid (RNAi, mRNA, saRNA) therapeutics.Specialties: Formulation and characterization of lipid nanoparticle (LNP) formulations and RNAi conjugates; Development of nucleic acid drug products including RNAi, mRNA and saRNA; Production of complex drug product batches at various production scales; Scale up and optimization of manufacturing processes suitable for clinical development and commercial manufacturing; Characterization of final product configurations including lyophilized products; Technology transfer and oversight of drug substance and drug product manufacturing; Management of supply chain.
Acuitas Therapeutics
View- Website:
- acuitastx.com
- Employees:
- 77
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Director, Chemistry, Manufacturing And Controls (Cmc)Acuitas TherapeuticsSquamish, Bc, Ca
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Director, Chemistry, Manufacturing & Controls (Cmc)Acuitas Therapeutics Jun 2020 - PresentVancouver, British Columbia, Ca• Project and technical management of CMC aspects of partnered programs.• Coordination and execution of technology transfer activities related to manufacturing of lipid nanoparticle (LNP) therapeutics.
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Senior Manager, ManufacturingGenevant Sciences Apr 2018 - Jun 2020Vancouver, British Columbia, Ca• CMC technical management of internal and alliance programs.• Managed the production of drug product batches for nucleic acid therapeutics based on lipid nanoparticle (LNP) and RNAi conjugate technologies to support clinical development.• Responsible for technology transfer of LNP manufacturing to contract sites (CMOs) and oversight of drug substance manufacturing. -
Senior Manager, ManufacturingArbutus Biopharma Corporation Jul 2015 - Mar 2018Warminster, Pennsylvania, Us• Coordinated the manufacture and analytical testing of preclinical and GMP lipid nanoparticle (LNP) drug product batches, onsite and at contract organizations (CMOs). • Developed and optimized manufacturing processes at various process scales to support internal and partner programs in clinical development.• Responsible for technology transfer and management of critical raw materials: custom lipid and drug substance (siRNA) manufacturing.• Oversight of supply chain including drug product distribution. -
Senior Manager, ManufacturingTekmira Pharmaceuticals Jan 2011 - Jun 2015• Coordinated technology transfer and production of drug product batches for product pipeline and corporate alliances.• Development and scale-up of LNP manufacturing processes including particle formation, tangential flow filtration (TFF) and sterile filtration processes suitable for late stage clinical development.• Management of supply chain including distribution of drug product to clinical sites.
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Manager, ManufacturingTekmira Pharmaceuticals Jan 2008 - Dec 2010• Managed the development, characterization and manufacture of preclinical LNP formulations and GMP clinical batches for internal and partner programs.• Technical lead for technology transfer to contract sites (CMOs) including oversight of sterile filtration and aseptic filling operations.
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Senior Associate, Process DevelopmentTekmira Pharmaceuticals May 2007 - Dec 2007•Coordinated and conducted experiments to develop, optimize and prepare LNP formulations for internal projects and partnering companies at various process scales.•Organized activities for preclinical and Phase I GMP batch manufacture.
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Senior Associate, Research And Process DevelopmentInex Pharmaceuticals Jan 2004 - Apr 2007•Designed and conducted experiments to develop lipid nanoparticle (LNP) formulations and optimize processes for the product pipeline and corporate partners.•Supervised and participated in the manufacture of drug product batches to support clinical development programs.•Developed scalable processes including equipment design and validation (IQ/OQ/PQ).•Prepared procedures (SOP's), batch records, study protocols and reports. -
Associate, ResearchInex Pharmaceuticals Feb 2000 - Dec 2003•Performed scale-up and formulation development studies as a member of a multidisciplinary team involved with the transfer of drug candidates from research into clinical development.•Screened small molecule drug candidates for the liposomal drug delivery platform.•Prepared formulations for preclinical development.•Designed analytical methods to characterize LNP formulations and biological samples.
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Research AssistantUniversity Of British Columbia Aug 1998 - Nov 1999Vancouver, British Columbia, Ca•Isolated and analyzed lipids from pulp mill process waters using solid-phase extraction. •Developed an ELISA to rapidly and effectively measure resin acids in process streams and compare against conventional analytical methods (LC, GC).
Rob Leone Skills
Rob Leone Education Details
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The University Of British ColumbiaApplied Microbiology -
The University Of British ColumbiaMicrobiology And Immunology
Frequently Asked Questions about Rob Leone
What company does Rob Leone work for?
Rob Leone works for Acuitas Therapeutics
What is Rob Leone's role at the current company?
Rob Leone's current role is Director, Chemistry, Manufacturing and Controls (CMC).
What is Rob Leone's email address?
Rob Leone's email address is rl****@****ira.com
What schools did Rob Leone attend?
Rob Leone attended The University Of British Columbia, The University Of British Columbia.
What skills is Rob Leone known for?
Rob Leone has skills like Manufacturing, Gmp, Process Development, Process Optimization, Formulation Development, Technology Transfer, Sop, Process Validation, Lyophilization, Drug Delivery, Drug Development.
Who are Rob Leone's colleagues?
Rob Leone's colleagues are Sherry Weppler, Sungbum Kim, Miranda Lam, Kc, Fergal Delaney, Marissa Grosz, Carmen Ylanan, Thomas Chamberlain.
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