K-NIBRT

EDUCATION

• 2007 – 2014 Kangwon National University(Kangwon-do, Korea)
• Bachelor’s in biotechnology engineering

PROFESSIONAL CAREER SUMMARY

• Dec. 2017 ~ Present Sartorius Korea Biotech
  Key Account Manager, Product Manager / Life Science Research Team
• Dec. 2015 ~ Nov. 2017 Korea Biotechnology Industry Organization (KoreaBIO)
  Associate Manager / Bio Specialist Training Unit
• Nov. 2013 ~ Nov. 2015 EmageneScience
  Technical Sales Engineer / Life Science Department

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

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

학력 및 주요 경력

• 2001 - 2008 성균관 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 – 현재싸토리우스코리아바이오텍

연구 및 저서

• 2012.07팜텍 기고문 작성
• 2015 - 2016sureGMP 기고문 작성 (vol. 16,17,18)
• 2019고등학교 교과서, ‘바이오시밀러’ 교재 편찬

Education

• 1996. 2순천향대학교 대학원 (미생물학) 이학석사
• 2007. 2고려대학교 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

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 - 2020 Janssen
• 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

• 2006 - 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

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.

Work Experience

[ 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

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 areas

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

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)

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

Research Area

• 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

교육

• 1989. 2한양대학교 생명과학과 학사
• 1993. 2한양대학교 생명과학과 발생생물학 석사
• 1999. 8한양대학교 생명과학과 발생생물학 박사

경력

• 1993. 8. 1. ˜ 2008. 2. 28: 제일병원 생식생물학 및 불임연구실 연구실장
• 2000. 3. 1. ˜ 2001. 8. 15: University of Pennsylvania, CRRWH Post-Doc Fellow
• 2008. 3. 1 ~ 현재: 을지대학교 임상병리학과 교수
• 2018. 1. 1 ~ 2022. 12. 31: 대한남성과학회 부회장
• 2021. 1. 1 ~ 2022. 12. 31: 대한생식면역학회 회장
• 2022. 1. 1 ~ 현재: 대한의생명과학회회장