Louanne King
Director, Regulatory Affairs at LFB USA- Claim this Profile
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Bio
Glen Firth
Louanne is an experienced and technically knowledgeable process engineer. I worked directly with Louanne to oversee manufacturing activities outsourced to CMO's. She has always been very thorough and detail oriented in her efforts to track, trend, and analyze critical process data, as well as execute validation of process equipment, CIP, and manage process and quality systems changes. She possesses very strong report writing skills and works well with individuals at all levels and functions across the Manufacturing Operations organization. Louanne's support during inspections by multiple regulatory agencies was critical to the successful commercialization of ATryn (recombinant human antithrombin). I give a strong recommendation for Louanne and her performance history as a key contributor in Manufacturing Technical Operations.
Glen Firth
Louanne is an experienced and technically knowledgeable process engineer. I worked directly with Louanne to oversee manufacturing activities outsourced to CMO's. She has always been very thorough and detail oriented in her efforts to track, trend, and analyze critical process data, as well as execute validation of process equipment, CIP, and manage process and quality systems changes. She possesses very strong report writing skills and works well with individuals at all levels and functions across the Manufacturing Operations organization. Louanne's support during inspections by multiple regulatory agencies was critical to the successful commercialization of ATryn (recombinant human antithrombin). I give a strong recommendation for Louanne and her performance history as a key contributor in Manufacturing Technical Operations.
Glen Firth
Louanne is an experienced and technically knowledgeable process engineer. I worked directly with Louanne to oversee manufacturing activities outsourced to CMO's. She has always been very thorough and detail oriented in her efforts to track, trend, and analyze critical process data, as well as execute validation of process equipment, CIP, and manage process and quality systems changes. She possesses very strong report writing skills and works well with individuals at all levels and functions across the Manufacturing Operations organization. Louanne's support during inspections by multiple regulatory agencies was critical to the successful commercialization of ATryn (recombinant human antithrombin). I give a strong recommendation for Louanne and her performance history as a key contributor in Manufacturing Technical Operations.
Glen Firth
Louanne is an experienced and technically knowledgeable process engineer. I worked directly with Louanne to oversee manufacturing activities outsourced to CMO's. She has always been very thorough and detail oriented in her efforts to track, trend, and analyze critical process data, as well as execute validation of process equipment, CIP, and manage process and quality systems changes. She possesses very strong report writing skills and works well with individuals at all levels and functions across the Manufacturing Operations organization. Louanne's support during inspections by multiple regulatory agencies was critical to the successful commercialization of ATryn (recombinant human antithrombin). I give a strong recommendation for Louanne and her performance history as a key contributor in Manufacturing Technical Operations.
Credentials
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Six Sigma Process Improvement
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Experience
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LFB USA
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United States
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Biotechnology Research
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1 - 100 Employee
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Director, Regulatory Affairs
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Aug 2022 - Present
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Director, Commerical Manufacturing & Product Lead
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May 2017 - May 2022
• Direct oversight for external Commercial Manufacturing Organizations (CMOs) for commercial intermediate and final fill sites and internal manufacturing for intermediate product. • Technical program management and team leadership across all functional groups to create a high level teamwork accomplishment and maintain collaborative relationships with Pharmaceutical Sciences, QC, QA, Regulatory Affairs, Supply Chain, Finance, and external alliance partners. • Subject Matter Expert (SME) for all government inspections and major contributor to regulatory filing submissions. • Lead investigations, solve problems with time constrictions, and assess process capabilities for manufacturing utilizing Six Sigma tools, Risk Assessment, Root Cause Analysis, FMEACA, and risk based approach concepts. • Coordinate manufacturing and shipping schedules for raw material, DS and DP to meet expected timelines. • Created trending data base that monitors process performance which enhanced manufacturing capability, increased process control, and improved product quality. • Monitor and manage budget costs associated with commercial manufacturing operations and create purchase orders for SOWs and CMO contract obligations. • Author technical and validation documentation, SOP's, Master Production Records, CAPAs, Change Control, and Deviations. • Developed microbial control strategy and leachable/extractable evaluation procedure for commercial manufacturing process. • Maintained oversight of successful Phase II (pre-clinical/clinical) 0.5MM Capital Scale-up Project including URS, Design Specification, FAT/SAT, Validation Project Plan • Proficient in Microsoft Excel, Word, PowerPoint, MINITAB and Project. • 2012 President’s Award for process optimization and overall product yield improvement Show less
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Associate Director, Commercial Manufacturing
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Jul 2015 - May 2017
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Associate Director, Technical Operations
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Jul 2014 - Jul 2015
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GTC Biotherapeutics
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Biotechnology Research
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1 - 100 Employee
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Process Engineer III/IV, Technical Operations
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Mar 2004 - Jul 2014
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Unither Pharmaceuticals
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Process Development Scientist
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Jan 2003 - Feb 2004
- Technical representative of contract manufacturing and final fill facilities. - Specified and ordered equipment for manufacturing facility and quality control laboratories. - Developed and authored comparability reports and other specified documentation. - Created and maintained yield tracking database. - Technical representative of contract manufacturing and final fill facilities. - Specified and ordered equipment for manufacturing facility and quality control laboratories. - Developed and authored comparability reports and other specified documentation. - Created and maintained yield tracking database.
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Millennium Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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Manufacturing Supervisor
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Feb 2002 - Jan 2003
- Recipient of two Star Awards recognizing outstanding efforts in reaching and exceeding project expectations. - Supervised a team of eight operators with the successful technical transfer and accelerated process manufacture (cell culture through final formulation) of a monoclonal antibody for Phase I human clinical trials. - Responsible for planning daily activities per the project timeline and updating management on project status. - Coordinated the resolution of all Quality Assurance, Quality Control and Manufacturing issues. - Assisted in developing a novel modular manufacturing system for the cGMP manufacture of biopharmaceuticals. - Assisted with the development and validation of 21 CFR Part 11 compliant electronic documentation system for cGMP production. Show less
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Biovest International
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United States
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Financial Services
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1 - 100 Employee
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Sr. Mfg Associate
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1999 - 2002
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Alpha-Beta Technology
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United States
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Research Services
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Sr. Mfg Technician/Associate
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1993 - 1999
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Education
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1997 - 2003
Worcester State College
Bachelor's degree, Natural Sciences concentrated studies in Chemistry/Mathematics -
2007 - 2007
Worcester Polytechnic Institute
Six Sigma Process Improvement Certificate, Six Sigma
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