Douglas Daley Email and Phone Number

Primary functions include establishing cell culture protocols and specifications for new products from Research and Development (R&D) and outside depositors (new accessions) to facilitate tech transfer process to manufacturing. Serve as a mentor to cell manufacturing department and provide technical support as needed. Utilize Design of Experiments (DOE) to perform experiments and support MS&T team projects. Leverage Lean Six Sigma to identify and execute process improvements. Investigate new technologies and validate acquired equipment. Lead root cause analyses, implement change control process, initiate corrective and preventative action plans (CAPAs), and identify nonconformities in manufacturing process.

Responsibilities include using Lean Six Sigma to identify and execute laboratory and process improvements through our OpEx and serving as technical specialist for custom contracts. Additional duties include maintaining automated equipment (SelecT and Monobloc vial filler/capper/labeler system), updating and authoring SOPs defining laboratory procedures and mentoring new employees in aseptic technique and cell culture processes.

Performed the expansion of animal and human tissue cell cultures. I've produced more than 50,000 ampoules of cell culture material for more than 200 different cell lines. I'm experienced working with an array of cell types and morphologies including lymphoblasts, fibroblasts, epithelial cells, aggregates, hybridomas and mouse embryonic fibroblasts(stem cell feeder layer cells). Led majority of technology transfer projects and assignments since 2009, including generating a cell line specific "process parameter" to describe growth characteristics and requirements for newly accessioned materials. Organized a team of biologists to systematically generate accurate Bill of materials for the more than 3600 cell lines at ATCC. Developed an easy to follow SOP to stream-line the process of gernerating Bill of Materials. Successfully delegate responsibilities through use of an Excel spreadsheet. One of 2 primary operators of the automated SelecT system. I decide what cell lines are quality candidates for growth on the SelecT system by reviewing the history and growth characteristics of the cell lines. Produce master cell bank and production material for special contract work. Have experience working with multiple cell culture technologies, including cedex, vi-cell, hemocytometer, Fill-It, SelecT, Filamatic, peristaltic pumps, i-fills, and multiple labeling systems. Team member in process development and process validation projects for cell line production including expansion and vialing protocols to enhance and optimize overall production processes.