CURRICULUM
과정소개
교수진 소개
기술자문위원
권기원
Gi-Won Kwon
Key Account Manager, Product Manager Sartorius Korea Biotech
- kwongiwon88@gmail.com
김경민
Kyoung Min Kim
CEO of BioSupport Co., Ltd.
- quality@biosupport.co.kr
김기동
Ki Dong KIM, CEO
CEO, kapable FnC
- kdkim57@naver.com
김영태
Youngtae Kim
Sartorius Korea Biotech LLC Director
- Ryan.kim@sartorius.co.kr
민혜경
Hyekyoung Min
MinLab, Director
- bsmhg61@naver.com
오덕석
DeokSeok Oh
Janssen, Former Head of QA
- ejrtjr@gmail.com
유영하
Youngha Yu
Senior Specialist, samsung biologics
- youngha.yu@samsung.com
이장한
Janghan Lee
Senior Researcher, K-Bio Health
- hanymir@kbiohealth.kr
이회석
Hoe-Suk Lee
Post-Doc Researcher, Department of Biochemical Engineering, Gangneung-Wonju National University
- HSL0828@snu.ac.kr
전재혁
JEON JAE HYUK
- jjh0209@itp.or.kr
전진현
Jun, Jin Hyun
Professor, College of Health Sciences, Eulji University
- junjh55@hanmail.net
권기원 바이오써포트 대표
Gi-Won Kwon, Key Account Manager, Product Manager Sartorius Korea Biotech
- kwongiwon88@gmail.com
EDUCATION
- 2007 - 2014Kangwon National University(Kangwon-do, Korea)
Bachelor’s in biotechnology engineering
PROFESSIONAL CAREER SUMMARY
- Dec. 2017 ~Sartorius Korea Biotech
Key Account Manager, Product Manager / Life Science Research Team - Dec. 2015 ~
Nov. 2017Korea Biotechnology Industry Organization (KoreaBIO)
Associate Manager / Bio Specialist Training Unit - Nov. 2013 ~
Nov. 2015EmageneScience
Technical Sales Engineer / Life Science Department
김경민 CEO of BioSupport Co., Ltd.
Kyoung Min Kim, CEO of BioSupport Co., Ltd.
- quality@biosupport.co.kr
학력
- 1987~1993성균관대학교 식품생명공학학사
- 1993~1996성균관대학교 식품생명공학석사
- 1994~1995일본 오카야마대학(岡山大學) 농학부(Micro-lab) 특별연구생
경력
- 2016~현재㈜바이오써포트 대표이사
- 2003~현재㈜바이오써포트 대표컨설턴트
- 2016~2021㈜한국제약기술교육원(KPTEC) 대표이사
- 2018~현재PDA Korea(The Parenteral Drug Association) 수석부회장
주요활동
- 2021~현재K-NIBRT사업단 자문위원
- 2007~현재한국제약기술교육원(KPTEC) GMP 및 밸리데이션 교육과정 전임강사
- 2014~현재한국보건산업인력개발원 GMP교육과정 강사
- 2013~2021한국PDA·팜텍 운영위원회 운영위원
- 2019~2020약대 제약실습 연계교육 프로그램, 이화여대 약대 강사
김기동 ㈜케이퍼블 대표이사 CEO
Ki Dong KIM, CEO
- kdkim57@naver.com
학력
- 1987-1991University of Reading UK Dept. PhysioLogy & Biochemistry PhD in MoLecuLar BioLogy (이학박사)
- 1982-1985고려대학교 대학원 생식생리학 전공 (MSc 이학석사) “Mouse 및 Rat 난자의 동결보존에 관한 연구”
- 1976-1982고려대학교 응용동물과학과 (BSc 이학사)
경력
- 2021-현재㈜케이퍼블 대표이사 CEO
진균세포와 조직을 이용한 biofabrication technology 개발 - 2017-2020㈜넥스바이오 고문, 과학기술경영
인간 혈우병 치료제(유전자재조합 단백질 Factor VIII)의 임상시험 총괄책임자, 해외 임상 시험 준비 및 데이터 관리 - 2017-2020㈜ BIOXSINE KOREA CTO
탈모 관련 기능성화장품(샴푸, 헤어세럼 등) 국내 등록을 위한 처방의 개 발과 인체적용시험 시행 및 식약처 심사 - 2015-2018㈜ 나담코스 고문 (기술경영 및 개발)
유기농 화장품 개발과 유럽기준 유기농 인증 (COSMOS 인증 취득) - 2014-2015 ㈜ 루바마네이처 기술개발 책임자
유기농 화장품 등을 위한 천연 방부제 개발 (특허 1018068000000) - 2009-2014㈜ BMBS 대표이사 CEO
진단용 의료기기 및 진료 device 개발 - 2002-2008㈜ 임젠 대표이사 CEO
생쥐 및 인간 역분화 줄기세포 치료제의 개발 (특허 목록 참조) - 2000-2002서울대학교 농생명과학부 조교수
- 1995-2008고려대학교 생명과학대학 강사
- 1990-1994University CoLLege London UK, MedicaL SchooL (Dept. MoLecuLar Endocrino
김영태 싸토리우스코리아바이오텍(유) 부장
Youngtae Kim, Sartorius Korea Biotech LLC Director
- Ryan.kim@sartorius.co.kr
학력 및 주요 경력
- 2001-2008성균관 대학교 화학공학과 학사 졸업
- 2010-2013고용노동부 총괄, 바이오공정 핵심기술 전문인력양성 사업, 강사 역임
삼성바이오로직스, SK Chemical, 녹십자 등 제약사 강사 역임 - 2022식약처 GMP 조사관 교육 강사 역임
- 2008-현재싸토리우스코리아바이오
연구 및 저서
- 2012.07팜텍 기고문 작성
- 2015-2016sureGMP 기고문 작성 (vol. 16,17,18)
- 2019고등학교 교과서, ‘바이오시밀러’ 교재 편찬
민혜경 민랩 이사
Hyekyoung Min, MinLab, Director
- bsmhg61@naver.com
Education
- 1996.02순천향대학교 대학원 (미생물학) 이학석사
- 2007.02고려대학교 대학원 (분자의과학) 이학박사
Professional Experience
- 2018~현재민랩 이사
- 2017~2020㈜ 중겸 이사
- 2016~2017식품의약품안전평가원 의료기기 연구과 보건연구관
- 2012경인청 시험분석센터 수입식품분석과, 유해물질분석과 (식품관련 시험) 보건연구관
- 2011식품의약품안전청, 의료기기안전 국, 체외진단의료기기 T/F 팀 보건연구관
- 2009식품의약품안전청 생물제제과 보건연구관
- 2006식품의약품안전청 생물진단의약품과 보건연구사
오덕석
DeokSeok Oh, Janssen, Head of QA
- ejrtjr@gmail.com
Education
- 1998-2007Bachelor of Science in Biological Sciences Seoul National University Seoul, Korea
Work Experience
- Head of QA
- 2020-PresentJanssen Lead of NPI & Commercial Manage three teams (QA NPI/Product, QA Commercial & QA Lab) Certified QL (Quality Leader) for investigation / Certified Auditor FDA inspection in 2022 & 2023
- Manager of MSAT (Manufacturing Science and Technology
- 2016-2020Janssen Lead of Aseptic & Sterilization Technical transfer of new product from Janssen R&D Member of aseptic manufacturing council, J&J MQSA J&J AP101 trainer (topic: Aseptic Process Simulation)/J&J AP201 trainer (topic: Contamination Investigation)
- Validation & Quality Engineering
- 2014-2015Janssen Aseptic Process Simulation Cleaning Validation
- QA Manager of Global Pharma TFT
- 2012-2014Kolon Group Overseas pharmaceutical project in West Africa
- Part Leader of Validation & Compliance QA
- 206-2011Hanmi Pharmacetical Plant construction project (cephalosporin) New line project (power injection) MHRA (UK) inspection in 2008 & 2011
Professional Experience
- PDASteering committee member of PDA Asia Presentation at PDA conference (topic: APS intervention and smoke study) PDA Asia pacific service appreciation award, April 2023
Vice President of PDA Korea chapter Presentation at PDA workshop (topic: Contamination Control Strategy) - K-NIBRTPresentation at K-NIBRT (topic: Fill and Finish) PQM
- PQMLocal community member with Korean Health Authority Award from MFDS Gyeongin regional office, December 2015
유영하
Youngha Yu, MBA
- youngha.yu@samsung.com
Summary
- Over 12 years of experience in biopharmaceutical, pharmaceutical, and CDMO sectors
- Boundary spanning leadership through experiences in manufacturing operations, quality management, ITSM, DX, PI, etc.
경력
- [Samsung Biologics] Business Innovation / Unit Lead
- Manage MES (Manufacturing Execution System) development & operations
- Project management of DX (Digital Transformation) & PI (Process Innovation)
- Manage CSV (Computer System Validation) & CSA (Computer Software Assurance) process
- Manufacturing innovation TF / In charge of PMO management
- Quality Assurance
- CMC quality assurance for Drug Product (DP)
- DP (Drug Product) technical quality
- DP (Drug Product) quality operations, general
- In charge of clinical product introduction & management
- [SK biotek, an SK pharmteco company] Quality Assurance
- DS (Drug Substance) quality operations, general
- R&D quality operations, general
- Batch disposition & warehouse management
- In charge of SCQ (Supply Chain Quality) management
- In charge of CMO management / Lead auditor
- [CKD (Chong Kun Dang) Pharmaceuticals] DP Manufacturing Operations / Manufacturing Supervisor
- In charge of DP (Drug Product) manufacturing operations management
- In charge of global plant expansion project for EU market
- In charge of sterile fill-finish and manufacturing technology management
- Managed and experienced from investigational and clinical products to commercial products / ETC & OTC
- Managed pharmaceutical formulations
- SVPs (Small Volume Parenteral Solutions)
- LVPs (Large Volume Parenteral Solutions)
- Ophthalmic solutions (Eye drops)
- Oral liquids (drink pouches / bottles) - Managed pharmaceutical manufacturing system & technology
- RABS (Restricted Access Barrier System)
- BFS (Blow-Fill-Seal)
- PAT (Process Analytical Technology)
- Lyophilization
- Pharmaceutical packaging
- Serialization (Track & Trace)
Other Experience
- [PDA Korea Chapter] Regional Operations Manager / Board Director
- Provide support to the regional country chapter and host annual conferences
- High-quality interpretation and education of new regulations
- Presenting a new approach and guideline for the introduction of new technology into the industry
- Editorial director in the bioindustry field of PharmTech, a journal specializing in GxP regulations and biopharmaceutical manufacturing technology
이상훈
SANG HOON LEE, Ph.D.
- sang.lee@ablbio.com
EDUCATION
- Ph.D. in Molecular, Cellular and Developmental Biology, The Ohio State University, Columbus, OH
- M.S. in Developmental Biology, Seoul National University, Seoul, Korea
- B.S. in Biology Education, Seoul National University, Seoul, Korea
EXPERIENCE
- ABL Bio, South Korea CEO and FOUNDER 2016- Present
- CEO and Founder of ABL Bio (KOSDAQ 298380)
- Lead fund raising
- Successful IPO in KOSDAQ market in 34 months (Dec, 2018): 90 MM USD
- Lead, build, and manage entire business operations
- Hanwha Chemical, South Korea HEAD OF BIO DIVISION & SENIOR VICE PRESIDENT (2013-2016)
- Head of Bio Division - General Management of Bio organization and operation - Lead R&D including biosimilar and new drug discovery - Scientific and strategic leader - Lead cGMP facility at Osong cGMP facility - Manage operating and capital budgets
- PharmAbcine, Daejun, South Korea CO-FOUNDER and CSO (2009-2013)
- Head of R&D and lead Business Development
- Responsible for fund raising
- Exelixis, South San Francisco, CA SENIOR SCIENTIST II/ ASSOCIATE DIRECTOR, MOLECULAR & CELLULAR PHARMACOLOGY (2008-2009)
- Lead target validation and lead optimization for oncology discovery projects
- Lead in vitro mechanism of action (MOA) study, developing mechanistic cell-based assays and PK/PD studies for oncology discovery projects
- Support translational research for PI3K inhibitor (XL147), PI3K/mTOR dual inhibitor (XL765), IGF1R inhibitor (XL228) and S1P1R antagonist
- Genentech, Inc., South San Francisco, CA GROUP LEADER/SCIENTIST, ONCOLOGY PHARMACODYNAMIC BIOMARKERS (2005-2008)
- Group leader for Oncology Pharmacodynamic Biomarker Group
- Sub-team leader of oncology diagnostic team to provide diagnostics strategy for the discovery and development of predictive biomarkers
- Managed 7 peoples including 2 scientists and 5 research associates
- Oversee development and implementation of quantitative RT-PCR including TLDA array, immunoassays, Luminex, Rules based medicine (RBM), Meso Scale Discovery (MSD), immunohistochemistry and FACS assay including intracellular phospho-flow cytometry assays into Phase I trial
- Participate in biomarker strategic reviews of Genentech late stage research and early development pipelines for oncology and hematological oncology area
- AstraZeneca R&D Boston, Waltham, MA PRINCIPAL SCIENTIST, CANCER BIOSCIENCE (2004 - 2005)
- Project leader of AstraZeneca and Abgenix collaboration for developing therapeutic monoclonal antibodies
- Involved in global AstraZeneca global team for novel oncology target discovery
- Lead planning and implementation of strategies for tissue bank specimens from preclinical models and support translational research
- Chiron Corporation, Emeryville, CA (Currently Novartis) PRINCIPAL SCIENTIST, TRANSLATIONAL MEDICINE (2002-2004)
- Lead proof-of-concept, preclinical PK/PD, pharmacodynamic biomarker discovery and development for CHIR-258, multiple receptor tyrosine kinase small molecule inhibitor and support clinical development and biomarker strategies (TKI-258, currently in Phase II by Novartis ).
- Oversee and responsible for in vitro MOA, preclinical PK/PD, cell-based pharmacodynamic biomarker discovery for CHIR-265 (Raf and RTK inhibitor; currently in Phase II by Novartis)
- Lead MOA, Biomarker and Translational Research for anti-CD40 monoclonal antibody, HCD-122 (currently in Phase II by Novartis)
- Participated in strategies for publication and presented data at relevant scientific meetings for small molecule kinase inhibitor CHIR-258 and anti-CD40 monoclonal antibody
- Managed up to 10 people including 2 scientists and 8 research associates
- RESEARCH SCIENTIST II, CANCER PHARMACOLOGY (2000-2002)
- Responsible for in vitro and in vivo pharmacology studies for kinase small molecule inhibitor projects
- Planned and performed PK/PD study using xenograft tumor models
- Conducted research program for in vitro and in vivo studies for protein-based anti-angiogenesis therapy
- Evaluated novel anti-angiogenic therapies, internal and external
- Led early discovery research project: Regulation of VEGF by beta-Catenin in colon cancer
- Study erythropoietin receptor signaling on vasculogenesis and angiogenesis using knockout mice
이장한
Janghan Lee
- hanymir@kbiohealth.kr
Education
- 2020~2022Ph.D. (cand.): Industrial pharmacy, Chungbuk national university
- 2008~2010M.S.: Molecular biotechnology, Korea university
- 2002~2007B.S.: Biotechnology, Sejong university
Work experience
- 2015~presentNew drug development center, Osong medical innovation foundation
- 2012~2015R&D center, Hanwha chemical
- 2010~2012R&D center, TS corporation
Research / interest field
- Therapeutic protein, antibody, vaccine and cell & gene therapy (Biopharmaceuticals)
- Upstream process development & characterization (Quality by design)
- Bioreactor scale-up & tech. transfer (Manufacturing platform technology)
이회석
Hoe-Suk Lee, Post-Doc Researcher, Department of Biochemical Engineering, Gangneung-Wonju National University
- HSL0828@snu.ac.kr
Academic Experiences
- 2008.08BSc Biochemistry. Department of Life Science, Imperial College London, United Kingdom
- 2019.08PhD Bioengineering. Interdisciplinary Program of Bioengineering Seoul National University, Republic of Korea
- 2019.09 ~ CurrentPost-Doc Researcher. Department of Biochemical Engineering, Gangneung-Wonju National University, Republic of Korea
PhD Thesis
- Study on the Structure-based Engineering of Hydroxy Acid Dehydrogenases for Improvement of Substrate Specificity
주요활동
- Biochemical engineering
- Protein and enzyme engineering
- In silico rational design of proteins
- Directed evolution of proteins
- In vitro / In vivo engineering of biocatalyst
- Development of proteins and transformed cells for industrial and medical applications
전진현
Jun, Jin Hyun, 을지대학교 보건과학대학 임상병리학과 교수
- junjh55@hanmail.net
교육
- 1989.02한양대학교 생명과학과 학사
- 1993.02한양대학교 생명과학과 발생생물학 석사
- 1999.08한양대학교 생명과학과 발생생물학 박사
경력
- 1993.08.01~2008.02.28제일병원 생식생물학 및 불임연구실 연구실장
- 2000.03.01~2001.08.15University of Pennsylvania, CRRWH Post-Doc Fellow
- 2008.03.01~현재을지대학교 임상병리학과 교수
- 2018.01.01~2022.12.31대한남성과학회 부회장
- 2021.01.01~2022.12.31대한생식면역학회 회장
- 2022.01.01~현재대한의생명과학회회장
전재혁 교수
JEON JAE HYUK
- jjh0209@itp.or.kr
- -
- -
Education
- 2024 Phd student, School of Inha University, Biological Sciences and Bioengineering
- 2015 MS, Soonchunhyang University, Marine Biotechnology
- 2009 BS, Soonchunhyang University, Marine Biotechnology
EMPLOYMENT EXPERIENCE
- 2023 Employer C: Bio Center, Incheon Technopark, Senior Researcher
- 2021 Employer B: Plasma Fractionation Center, Korean Red Cross, Researcher
- 2017 Employer A: National Marine Biodiversity Institute of Korea, Junior Researcher