Michael Bourland
Director - Technical Operations at Vertex Pharmaceuticals
- Role
- Director Technical Operations at Vertex Pharmaceuticals
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Michael Bourland
Diverse development experience from pre-formulation to commercial solid dosage forms…
Experience
Director Technical Operations
Jul 2012 — Present · Cambridge, 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.
Skills
- Quality by Design
- Formulation Development
- Technology Transfer
- R&D
- Gmp
- Pharmaceuticals
- Pharmaceutical Industry
- Formulation
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