Pankaj Ranjan Karn

Head of Complex Formulation Division @ Dongkook Pharm.

About

Specialities: • Pharmaceutical professional having BPharm, MPharm (Pharmaceutics) and PhD in Pharmaceutics (Korea) with an award from the Ministry of Education, Science and Technology (Korea) • Expertise in novel drug delivery technologies, namely liposomes, SNEDDS, solid dispersion, etc. and exposure to development and commercialization of pharmaceutical products using these technologies • Expertise in manufacturing liposomes using a specialized large scale up ‘supercritical anti-solvent’ technique • Experience of handing basic and advanced characterization tools for liposomes, emulsions and nanoparticles as well as animals for in vivo studies. • Work experience in both pharmaceutical company as well as academic institutions (lecturer, researcher, postdoc researcher) • Successfully developed generics, supergenerics (added value generics) in oral solid and liquid dosage forms, and working with the fixed dose combination products (IMD) in capsule and tablet dosage forms as well as the new drug development in the liquid dosage form. • Experience in formulation and development of ODT; knowledge and understanding of KFDA guidelines for drug approvals in Korea • Expertise in preparing regulatory documents (CTD or other technical documents) and experience of writing CTD for exporting products to various countries. • Proven ability to communicate seamlessly with various global partners such as CMOs, CROs, big pharma etc. as a part of collaboration or co-development program • Leading efficiently a part of formulation research team • 6 First Author SCI publications, 2 patents registered in Korea, and an author of a chapter of an eBook published from the Future Medicine Group • An excellent command and proficient in spoken and written Korean and acquired a Permanent Residency Visa (F-5) in Korea in 2016 • Maintain a multidisciplinary professional networks mainly in India and Korea

Country

South Korea

City

Gyeonggi

Industry

Pharmaceuticals

Skill

Microsoft Word, Nanoparticles, Drug Delivery, HPLC, Liposomes, Powder X-ray Diffraction, Pharmaceutics, Nanotechnology, Supercritical Fluids, In Vivo, In Vitro, Scanning Electron Microscopy, Drug Development, GMP, Research, Pharmaceutical Industry, Formulation, Targeted Drug Delivery, Coatings, Zeta Potential

Experience

Head of Complex Formulation Division

Dongkook Pharmaceutical Co Ltd

2024-3 - Present · 2 yrs 7 mos

Suwon, Gyeonggi-do, Korea

Leading the development of complex injectable formulations, including microspheres, liposomes, and advanced drug delivery systems (LNPs), for both Korean and global markets. Spearheading innovative projects from early-stage formulation to clinical translation, focusing on differentiated NDA 505(b)(2) long-acting injectables and related therapies. Oversee multidisciplinary teams and collaborate with global partners to advance strategic development, regulatory submission, and market entry.

Senior Manager, Formulation Research Team

Daewoong Pharmaceutical

2022-5 - 2024-3 · 1 yr 11 mos

Yongin, Gyeonggi, South Korea

Core responsibility - Intranasal Formulations (Nasal Spray), Device development and Drug-device combination product - Psychedelic Drug Development - Modified/extended-release formulations (oral solids, microspheres, TDS, liposomes) Additional responsibility - Microneedles - Nucleic Acid Therapeutics (mRNA-LNPs, Exosomes) - DW Overseas R&Ds (India, Indonesia & China) Management [Co-development Program]

Team Leader (Senior Manager), Formulation Research II Team

Whan In Pharm. Co., Ltd.

2020-9 - 2022-5 · 1 yr 9 mos

Gyeonggi, South Korea

Lead a Formulation team on NDA 505(b)(2) [extended/Modified-release (differentiated) products)] & ANDA projects in different dosage forms - ER tablets, microspheres long-acting injectable depot, transdermal patches, etc. Lead clinical studies (India & Europe) with TDS and microspheres and lead regulatory communications (INDs, Pre-IND meetings, SA, consultancy, etc.), manage communication with the business partners.

Team Leader, Formulation Team

Alvogen

2019-8 - 2020-9 · 1 yr 2 mos

Suwon, Gyeonggi-do, Korea

Lead a Formulation Team on NDA, Generic, and modified generic products for MFDS and EU Submissions Lead the clinical (Pilot BA/BE) Studies, support the Phase I and Phase III studies Manage the global connectivity and point of contact for Alvogen Korea R&D

Senior Specialist I (차장) - Formulation Team

Yuyu Pharma

2019-4 - 2019-7 · 4 mos

Suwon, Gyeonggi-do, Korea

Formulation and Process development of - Generics, Value-added/differentiated generics (oral solids & soft capsules) for MFDS Submission - Combination Products (soft capsules) - New drug (peptides) for ophthalmic applications Open innovation/Collaborative work with major Pharma

Senior Researcher (Manager, 과장) - Formulation Team

Yuyu Pharma

2016-4 - 2019-3 · 3 yrs

Suwon, Gyeonggi-do, Korea

Senior Researcher (Assistant Manager, 대리) - Formulation Team

Yuyu Pharma

2014-8 - 2016-3 · 1 yr 8 mos

Suwon, Gyeonggi-do, Korea

Postdoctoral Researcher

Yonsei University

2013-9 - 2014-8 · 1 yr

Songdo-dong, Incheon, Korea

Core areas: Liposomal formulations (thin film, ethanol Inj.), solid-lipid nanoparticles formulations Liposomal preparation using supercritical fluid methods Small-scale and pilot-scale manufacture Pre-clinical studies Conventional dosage forms (modified release formulations) Manuscript writing, communication & co-development

Associate Researcher

Yonsei University

2011-9 - 2013-8 · 2 yrs

Songdo-dong, Incheon, Korea

Yonsei Institute of Pharmaceutical Sciences

English Language Instructor

Chungnam National University

2010-3 - 2011-8 · 1 yr 6 mos

Yuseong-gu, Daejeon, Korea

BK21 Fellowship- Scientist

Chungnam National University

2009-9 - 2011-8 · 2 yrs

Graduate Program in Drug Development under NRF Korea

Program Coordinator BPharm.

Pokhara University

2008-3 - 2008-8 · 6 mos

Head of the Department of Pharmaceutical Sciences for BPharm. program Subjects taught - Pharmaceutical Engineering - Advanced Pharmaceutics and Drug Delivery Systems - Pharmaceutical Research

Lecturer

Pokhara University

2008-1 - 2008-8 · 8 mos

Department of Pharmaceutical Sciences, Pharmaceutical Engineering and Pharmaceutics Subjects taught - Basic Pharmaceutics - Advanced Pharmaceutics and Drug Delivery Systems

Assistant Lecturer

Pokhara University

2006-1 - 2008-1 · 2 yrs 1 mo

Department of Pharmaceutical Sciences, Pharmaceutics - Taught Basic Pharmaceutics and Pharmaceutical Engineering - Investigated the Practical Courses- Dosage forms

Education

Chungnam National University

Drug Delivery Systems

2009 - 2013 · 4 yrs

Dissertation title: Development of a novel liposomal cyclosporin A using supercritical fluid method for the ophthalmic application. Supervisor: Professor Sung-Joo Hwang, Yonsei University Co-supervisor: Prof. Jeong-Sook Park, Chungnam National University