Rob Leone Email & Phone Number

Squamish, Bc, Ca

Vancouver, 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.

Vancouver, 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.

Warminster, 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.

• 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.

• 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.

•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.

•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.

•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.

Vancouver, 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).

M.Sc., Applied Microbiology

B.Sc., Microbiology And Immunology