Highlights:

Skills:Microbiology Lab management, Quality system management, Quality Control lab management, CMC, Quality Assurance Management, GMP, FDA, EMA, Sterility Assurance

Sr. QC Director & Deputy QA head Apr 2022 - Jun 2024
Henlius Biopharmaceutical & Aton (shanghai) Biotech Co., Ltd., Shanghai, Shanghai China
Industry: Biopharmaceutical industry
?Establish quality management system, and manage, maintain and support monoclonal antibody and antibody drug conjugation clinical drug substance and drug product manufacturing. ?Lead a cross-function team to complete commission and qualification of new ADC manufacturing facility ?Hosted and assisted in numerous successful audit processes for regulatory bodies (EMEA, ANVISA, INVIMA and BPOM), customers and internal on-site inspections
Aton (shanghai) Biotech Co., Ltd is Henlius's subgroup company, and Aton focus on CDMO business. As the quality control analysis activities were contracted to Henlius's QC lab, I acted as both quality assurance and Quality control head to establish quality management system for CDMO business and products manufacturing. Lead the client quality system audit, and support clients to complete product manufacturing and regulatory document generation.--
Head of QC Sep 2020 - Mar 2022
Lonza Guangzhou Biologics Co., Ltd., Guangzhou, Guangzhou China
Industry: Biopharmaceutical industry
??Provide leadership for the Quality Control department to ensure that manufacturing operations are conducted at high quality and in compliance with current Good Manufacturing Practices.?Manage the Quality Control department and is responsible for Raw material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics.
Lead a team of more than 50 people to manage, operate and support biological product drug substance related analytical analysis, set up site MCC program to make sure contamination control during production process, and actively participate and contribute to Lonza GQC and external client audit.--
Sr. QC manager Jul 2014 - Sep 2020
Lilly Suzhou Pharmaceutical Co., Ltd., Suzhou, Jiangsu China
Industry: Pharmacutical industry
?Establish high standard quality control lab for filling project and cooperate site insulin product technical transfer activities, successfully faced Lilly GQAAC and EMA audit and drive solutions for inspection findings.
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Group Leader, Jul 2006 - Mar 2014
Novast Laboraories Ltd., Nantong, Jiangsu China
Industry: Pharmacutical industry
Set up a new microbiology lab and establish quality management system for operation to support oral solid product manufacturing, and successfully faced the USFDA AUDIT with zero observations in 2008 and 2013.
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China Pharmaceutical University 09/2002 - 06/2006
Nanjing, Jiangsu, China
Degree: Bachelor's Degree
Major:Biotechology
Study phase and learn pharmaceutical knowledges.

Kuanmei Feng Experienced Quality Control manager