Mike Bradley
Quality and Validation Expert in the Life Sciences Manufacturing Industry
- Role
- Validation Manager at Neurotech Pharmaceuticals, Inc.
- Location
- Cranston, RI, US
- LinkedIn followers
- 500 followers
About Mike Bradley
Extensive experience in biomanufacturing quality assurance, quality control, and validation. Quickly and comprehensively learns unfamiliar plant manufacturing equipment and processes with an ability to transition plants to lean manufacturing operations; builds and optimizes robust validation programs. Proven record of success planning, directing, and delivering high-value biotech development and manufacturing projects. Vast in-depth technical, quality, and compliance knowledge in all aspects of drug substance processing, sterility assurance, process control, computerized data systems, qualification, validation, cleaning, commissioning, and engineering. Innovative and efficiency-oriented while guaranteeing quality. Dynamic advocate for staff development and technical training. Ability to communicate complex issues in a simple way, explain logical flows, and translate strategy into action.Highlights of Expertise:cGMP & cGLP Guidelines Biomanufacturing, Cell Culture, and Pharmaceutical PurificationCQV: Equipment/Instrument Validation, Cleaning Validation, Steam Sterilization Validation, CTCs, Air Flow Visualization, Facillites, & UtilitiesChange Controls, CAPAs, and Deviations/Investigations and Quality Risk Assessments Plant Startup and Technology TransfersFTE Coaching/Mentoring and Contractor OversightRegulatory, Partner, and Internal InspectionsSOP & Document OptimizationEquipment Validation and Quality Control Testing
Experience
Validation Manager
Neurotech Pharmaceuticals, Inc.
Apr 2023 — Present · Cumberland, RI, US
Education
Bridgewater State University
Bachelor of Science (BS), Biology
1995 — 1999
Skills
- Mammalian Cell Culture
- Technology Transfer
- 21 Cfr Part 11
- Commissioning/Qualification
- Controlled Temperature Chamber Validation
- Purification
- Steam Sterilization
- Manufacturing
- Biotechnology
- Sop
- Biopharmaceuticals
- Cleaning Validation
- Innovation
- Raw Materials
- Utility Qualification
- Water Testing
- Standard Operating Procedure (Sop)
- Adherent Cell Culture
- Quality Control
- Gmp
- Aseptic Processing
- Validation
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