Michael Perry Email & Phone Number

United States

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Indianapolis, Indiana, Us

Project Manager CMC for Editas Medicine (October 2019-October 2020)• Provided project management support for tech transfer and execution of GMP fill/finish at new CMO GMP facility for early stage clinical trial. Responsibilities included initiating change control, coordinating batch record reviews, and actively tracking and coordinated completion of deliverables between CMO and internal team.• Provided project management support for coordination of assay transfer, development, and validation with third-party analytical lab. Track progress on assays and lead weekly status meetings and monthly business meetings. Continually update program core team with progress for potential impacts to IND filing and GMP readiness.Manufacturing and Facilities Engineering Support for Seres Therapeutics: (June 2016-January 2020)• Project manager for staff aug project with several deliverables: cleaning validation for the sanitizing and decon autoclaves, cleaning validation for a sonicator, IOQ of mixers, qualification of TCUs, qualification of EM air samplers, warehouse mapping, HVAC improvement projects, historian improvement projects.• Staff aug role to support manufacturing group. Regular work including change controls, impact and risk assessment, developing critical spare parts list, providing technical support for VHP system, and qualification of new equipment. • Qualified computerized systems Building Management System (BMS) and Historian.• Lead execution effort to commission Vaporized Hydrogen Peroxide (VHP) generation and distribution systems for major suite cleaning.• Developed protocols and lead execution effort for process gases and water utilities.• Performed facility User Requirement and Design Requirement review.• Lead development, execution, and scheduling effort to qualify multiple temperature controlled units (TCUs).• Performed asset registration for company’s CMMS. • Drafted SOPs for multiple pieces of equipment and facility systems.

Cambridge, Ma, Us

Intern for Process Engineering group supporting commercial GMP manufacturing. Work included: • Commissioned ultrafiltration/diafiltration skid for use in commercial manufacturing of Eloctate ™.• Reviewed process and instrumentation diagrams and electrical diagrams for accuracy.• Optimized process recipes in accordance with product Process Control Documentation.• Finalized Operational Qualification Protocols for allowing release of equipment to manufacturing.• Developed and ran Water for Injection (WFI) drop test protocol for testing the efficiency of individual drop heat exchangers.• Supported engineering and automation in classifying instrumentation for calibration and organizing equipment information.• Completed assessment on standalone equipment in purification suites for developing preventive maintenance schedules.

Cambridge, Ma, Us

Intern for the Downstream Process Engineering group supporting commercial GMP manufacturing. Work included:• Commissioned chromatography skids that will be used for a commercial drug campaign.• Performed a comparability assessment of in-line and offline refractive index instrumentation for clinical drug campaign.• Conducted a critical spare parts assessment on ultrafiltration systems in order to assure all spare parts were accounted for.• Developed and implemented a visual spare parts catalog to assist in future manufacturing.• Evaluated the efficiency of cleaning cycles for production support equipment in order to optimize wash cycles.• Performed an analysis of P&ID’s for multiple functional systems