Ed Louie Email & Phone Number

Belmont, Ca, Us

Cambridge, Cambridgeshire, Gb

Basking Ridge, New Jersey, Us

Lead and direct cross functional group to start-up and license new manufacturing facility, and secure commercial launch supply for excipient and micronized API to support Bevespi and pipeline products. • First cycle approval for Pearl’s first NDA.• Successful Pre-Approval Inspection 14 months after move into new site. Within 1 year, setup, commissioned, and qualified new manufacturing facility and equipment, and completed cleaning and process validation for two manufacturing processes.• Launched commercial API and Excipient manufacturing at site.• Develop site organization structure for PAI and commercial manufacturing readiness including: Manufacturing, Quality Control, Materials Management, Process Engineering, and Site Operations. • Co-lead program to uplift site capabilities

Gaithersburg, Maryland, Us

Lead and direct cross-functional team supporting GMP, GLP, and R&D operations at MedImmune’s three California locations totalling 215,000 sf. Functions include: Supply Chain Management; Facilities Engineering, Maintenance & Support; Environment, Health and Safety (EHS); and Lab Operations.• Led development and implementation of goals and metrics to focus and improve team performance and compliance. Reduced number of overdue GMP nonconformances to zero and increased training compliance to NLT 95%• Led team to prepare for successful FDA, MHRA, and internal compliance inspections. No critical or major observations.• Drove GMP Materials Management team to investigate and reduce materials shortages, avoiding manufacturing delays.• Led Logistics team to develop import/export procedures to reduce shipment delays, while ensuring compliance; developed training to enhance stakeholder awareness. Transfer of processes to Corporate Team to enhance support of global R&D stakeholders. • Planned and drove CA site consolidation including: evaluation of site locations, lab design and renovation; transfer of GLP clinical testing labs; decommissioning of GMP manufacturing and testing labs; development of future Site Operations organization and transition plan to ensure continuity of service to stakeholders.• Managed $20M Budget to within 5% of target

Gaithersburg, Maryland, Us

Reporting to VP of Manufacturing, led and directed a cross functional team to start up and license new BSL-2e manufacturing site for live-attenuated influenza vaccines.• Hosted successful FDA preapproval inspection three months after submission of sBLA• Developed licensure project plan and led execution to meet project milestones on time and on budget• Managed development and execution of process validation and comparability protocols• Performed gap analyses/risk assessments to identify and resolve compliance issues • Developed strong productive working relationships with Site Quality Team, Corporate Regulatory and Manufacturing groups, resulting in effective licensure team • Wrote, reviewed and edited sections of the sBLA, contributing to on-time regulatory submission• Provided project updates and represented California manufacturing site to corporate executive management to ensure timely resolution of open issues

Reporting to VP of Operations, directed GMP Manufacturing team of 30 for MyVax Personalized Immunotherapy, including Molecular Biology, Cell Line Selection, and Production groups. • Led and coordinated cross functional group (Manufacturing, Supply Chain, QC, QA, Validation and Process Development) to successfully transfer a new process from Development and manufacture conformance and stability lots.• Led and coordinated writing of BLA CMC Manufacturing sections. Major contributor to BLA Facilities Section. • Led investigative team to resolve final product pH deviation, enabling on-time initiation of conformance runs.• Led Manufacturing group to successful state inspection of new commercial manufacturing facility.

Reporting to VP of Operations, directed Production team for Phase 3 manufacture of personalized cancer vaccine. Functions included Cell Production, Purification, Aseptic Formulation and Fill, and Support. Strengthened and increased staff from 3 to 14.• Accomplished quality goals within first year of tenure. Developed and implemented batch records, SOPs, training curriculum, aseptic gowning and media fill qualification programs, cleaning and reprocessing qualifications, and final product vial qualification. • Improved process efficiency. Eliminated need for second shift by reducing labor/time for cell production and purification process.• Instrumental in design of 100,000 sq ft commercial manufacturing facility for 300 personalized therapies/month. Directed process engineers to develop equipment/utilities requirements, specifications, and design. Coordinated with contract engineers and architects to determine space, utilities and HVAC requirements. • Coordinated procurement effort for $4M process equipment/systems, including equipment specification, vendor selection, and SAT/FAT.

Managed Process Engineering and Validation groups. • Assisted clients with development of BOD, process/facility design, startup and validation. • Developed and reviewed PFDs, P&IDs, Utilities Utilization, and Process Equipment Specifications.• Collaborated with architects to define manufacturing space layout options. • Developed validation master plans, I/OQ and PQ protocols. Responsibilities included technical execution as well as project management, project staffing, employee development, and business development. Developed multiple new accounts for company.

Bs, Chemical Engineering

Ms, Chemical Engineering Practice

Che, Chemical Engineering