Blue Sage Engineering

Technical CMC guidance, including drug substance (DS) and drug product (DP) development, clinical supply, validation, commercialization, and commercial supply. My deepest experience is in formulation development, process design, and product characterization with an emphasis on novel processes and dosage forms. Oversee development, validation and manufacturing activities at client facilities or CDMOs. Strong technical understanding of solid and liquid dosage form unit operations. Mass transport and equipment operation. Complex system design and process control.

Design and development of biomedical devices and analytical instrumentation. Material selection and development of novel materials (e.g. oxidation-resistant polyethylene). Design of bespoke instrumentation for analysis of challenging materials and/or geometries (e.g. magnetorheology of magnetically-active fluids). Hardware design, software development, control system design and implementation.

Development of custom software for instrument/equipment control, data analysis, report generation. Web front-end development.