Nathan Smith Email & Phone Number

Pascoe Vale, VIC, AU

Melbourne, Victoria, Australia

Melbourne, Australia

Cell Therapies Pty Ltd (CTPL) is one of the most experienced contract manufacturers and distributors of cell-based therapies to patients all over the world. Our focus is on scaling manufacturing to reliably deliver time sensitive, patient specific product to meet client needs with control from needle-to-needle. Since 2003, CTPL has experience with a wide.

Framingham, Massachusetts, USA

• Managed the GMP cell bank manufacturing operations supporting commercial & clinical programs by driving process improvements, managing strategic direction & financial commitments, engaging with customers, and.
• Managed the cross-functional project team for the technology transfer of new and revised programs from development into GMP clinical & commercial cell bank manufacturing – from stakeholder proposal through change.
• Managed consent decree commitments pertaining to GMP cell bank manufacturing operations
• Supported construction activities to renovate GMP cell bank manufacturing facility, including design, vendor selection, commissioning & qualification, and turnover for GMP activities

New York City, New York, USA

• Managed contract manufacturing organization (CMO) GMP production, release testing, & supply chain logistics for human allogeneic adult stem cell therapy products for Phase II/III clinical trials
• Managed the extensive process development program at CMO for improvement and optimization of the adult stem cell manufacturing process with focus on lowering cost, improved regulatory compliance, secure supply.
• Coordinated the tech transfer of the newly developed phase III process into manufacturing at CMO to provide phase II/III clinical product supply
• Created and revised CMC sections for successful submissions to multiple regulatory agencies, including the FDA, EMA, TGA, HSA, etc.
• Managed development & tech transfer process of new autologous manufacturing process to CMO
• Revised and approved all statements of work, quality agreements, material service agreements and other manufacturing contracts

Rockville, Maryland, USA

• Managed the operation of 4 different business units:- GMP Cell Banking: contract GMP manufacturing of master and working cell banks for research, clinical trials and further manufacturing.- Client Cell Culture: culture.
• Managed the operation of business units responsible for contract cGMP cell bank manufacturing, media preparation for mycoplasma testing, client cell culture, sample preparation, & maintenance of virus and cell line.
• Successfully obtained EMA certification for contract GMP manufacturing of cell banks for client use in EU countries
• Extensive experience in cGMP manufacturing and testing while serving as Testing Facility Management for GLP studies
• Acquired expertise in small-scale aseptic processing of numerous mammalian, human, and insect cell lines and viruses, while employing lean manufacturing and six sigma tools to minimize waste and variation from routine.
• Hosted numerous client audits and visited multiple client sites in order to demonstrate processing capabilities and quality, build client relationships and establish partnerships

Rockville, Maryland, USA

• Managed day-to-day activities of contract cGMP Cell Banking Operations including scheduling of manufacturing, client communication and alliance-building, process improvement projects, budget, pricing and revenue.
• Designed process for quickly transferring client-owned cell bank manufacturing technical projects into BioReliance documentation to minimize manufacturing initiation timelines
• Designed $2.8 million cGMP cell bank production facility which was completed on time (within 9 months from groundbreaking to full facility validation) and under-budget with minimal impact to clients
• Successfully completed preventative actions in order to complete a major contamination investigation and defended findings to impacted clients
• Gained experience in small-scale aseptic processing of numerous mammalian, human, and insect cell lines, including adherent and suspension cell lines, animal-origin-free, serum-free and protein-free cell lines, and.

Supervised large-scale (up to 5000L) cell culture of CHO and hybridoma cell lines for the contract manufacture of monoclonal antibody and recombinant therapeutic protein bulk-drug substance

Supervised large-scale media formulation, buffer formulation and equipment cleaning/sterilization for the contract manufacture of monoclonal antibody and recombinant therapeutic protein bulk drug substance

Scheduled daily & long-term operations and managed optimization projects for media formulation, buffer formulation and equipment cleaning/sterilization to support the contract manufacture of monoclonal antibody and recombinant therapeutic protein bulk drug substance

Managed manufacturing support projects and long-term scheduling to support the contract manufacture of monoclonal antibody and recombinant therapeutic protein bulk drug substance