Luis Bloise Email & Phone Number

OE and Project Consultation for GMP Change Control, Deviation, CAPA, Quality Tools Training

South San Francisco

Lean Production System strategy development & deploymentCommercial Quality Leadership business process analysis and improvement

Davis, Ca

Technical support to protein biopharmaceutical Product/Technical Stewards focusing on:• Analytical data trending/analysis of Extavia & Proleukin products for quarterly/annual quality reports• Investigation support into manufacturing deviations and unexpected analytical results• Author/prepare technical memos, investigation, and trending reports

Novato, California

Business process development/improvement leader for Technical Operations accountable for developing/improving end to end (E2E) business processes, managing a portfolio of improvement projects, leading a business process improvement forum, and sponsoring a Lean 6 sigma training program.• Developed and documented a E2E business processes framework for Technical Operations.• Implemented business process governance for ownership, performance, improvement & metrics.• Mentored > 20 Lean Six Sigma Greenbelts on training, project selection, leading, and execution.• Facilitated Kaizen/VSM events in Supply Chain/Quality/Mfg. to reduce waste/enhance cycle time.• Created metric dashboards for using Safety, Quality, Execution, & Efficiency as core focus.• Single point of contact for consultants within Technical Operations to ensure alignment of efforts.

Senior Advisor Facility Impairment, 2010Accountable to coordinate and close all GMP documentation and training components associated with a Manufacturing facilityDocument & Change Control Leader, 2009 - 2010Responsible for change control/document process & staff engaged in ensuring GMP compliant change to systems and documents. Accountable to set the team’s vision, enhance the volume and velocity of compliant change, and develop the in-house staff. Manufacturing Startup Leader (200,00L CHO facility), 2004 - 2008Responsible for leading a multidisciplinary manufacturing team from conceptual design through qualification lots for licensure. Directly accountable for manufacturing collaboration to global process/automation engineering teams as well as the general contractor in the creation, procurement, and commissioning of world largest monoclonal antibody manufacturing plant ($700M+). Fermentation Startup Leader (144,000L CHO facility), 1997 - 2003Accountable for developing and leading a large scale cell culture manufacturing operation at the Genentech, Vacaville, CA site. This included hiring the right staff, developing its leaders, and leading the team from startup to 3.5 run/wk production.

Accountable for cGMP manufacture of clinical pipeline of monoclonal antibodies from working cell banks to contract filling. Leader of a 7x24 mammalian cell manufacturing operation through 4 manufacturing leaders – Inoculum Development, Fermentation/Media Prep, Downstream Processing/Buffer Prep, and GMP contract cleaning and filling. Represented Manufacturing on product launch teams.

Responsible for start up and GMP commissioning of the raw material/ dispense and media/buffer prep areas of a new e-coli manufacturing facility. Managed 3 production operations through 4 supervisors and crews on a 12 hr. rotating shift basis – Fermentation, Purification, and Buffer/Media Prep.

Responsible for the manufacture of 3 different licensed products on multiple shifts. Responsible for final target formulation, concentration, and bulk fill of final products through 3 lead operators, 25 regular employees, and 15 temporary employees.

Mba, Management Of Science & Technology

B.S, Decision Systems & Operations

Certified Black Belt, Lean Six Sigma

Certificate Of Process Mastery