Michael Bourland Email & Phone Number

Boston, Ma, Us

- Lead for commercial manufacturing automation efforts including advanced analytics, trending, connection to many outside and internal manufacturing manufacturing sites. - Lead the validation efforts (tech transfer, trouble shooting, manufacture of validation batches) for a Quality by Design batch manufactured tablet, including a successful PAI inspection- Responsible for the validation efforts for a fully continuous manufactured tablet (QbD product)- Lead technical operations activities for the design, build and qualification (IQ/OQ/PQ) of a fully continuous solid dose manufacturing line- The continuous solid dose manufacturing line includes traditional manufacturing unit operations for wet granule, dry granulated and directly compressed coated tablets as well as fully integrated PAT (RTRT), modeling capability and complex control systems. - Designing new control management software for continuous manufacturing line- Responsible for design, manufacture and implementation of a fully continuous manufacturing line for commercial products at an outside CMO.

Cambridge, Ma, Us

- Serve as the lead formulator on CMC teams for many projects- Lead formulation development projects for compounds in pre-Phase 1 through launch- Develop a wide range of formulations including: high dose, low dose, highly potent, cytotoxic, dry granulated tablets, wet granulated tablets, fluid bed granulated tablets, drug in capsule and powder in capsule- Utilize a variety of solubility enhancement techniques including lipids, spray dried dispersions, hot melt extrusions and milling during formulation development- Effectively manage CMO relationships - Author relevant drug product sections for several IND submissions- Initiated the effort to have a compaction simulator installed and used - Helped to lead implementation of Quality by Design (QbD) - Served as a Director of Britest Limited- Six Sigma Green Belt and Lean Six Sigma Trained

- Supported scale up of a dry granulated tablet for a cancer product from discovery to Phase 3 manufacturing of approximately 400kg batch sizes- Supported the scale-up and validation of a filling and packaging line for an inhalation product - Issued relevant drug product sections of regulatory documents for the filing of an inhalation product that was successfully filed and approved- Developed methods to analyze formulation development using less than 5g of powder- Participated in the filing of a smoking cessation (QbD filing) and an osteoporosis drug product- Conducted relevant Quality by Design experiments and methodologies- Investigated the use of process analytical technologies (e.g. online NIR) to improve process performance such as blend uniformity- Developed predictive multivariate performance models of roller compaction processes using neural networks and principal component modeling