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R&D
R&D

Biopharmaceutical Development
Conduct development of cell line, process, formulation, analysis method and production of non-clinical DS and DP batches
Manage documentation of quality-related regulatory approval data and liaise with relevant regulatory agencies

Novel Therapeutics Development
Discover new biopharmaceutical antibodies and conduct early research and non-clinical testing
Develop new platforms (ADC, multispecific antibody, etc.) and conduct business development through equity investment
Develop and co-develop new businesses (microbiome, data bank establishment, etc.)
Product Development
Product Development

Business Development
Manage biopharmaceutical product development
Establish new product development strategies and build product portfolios

Regulatory Affairs
Develop and execute domestic and international approval plan strategies and manage approvals
Respond to regulatory agencies regarding project approvals

Clinical Development
Conduct clinical trial planning, operations and global clinical supply chain management
Manage drug safety information and respond to regulatory agencies

Statistics and Data Management
Conduct statistical analysis of R&D, clinical trials, regulatory approvals, production and CMC and respond to regulatory agencies
Operate clinical data management and collection system

Chemical Product Development
Conduct synthetic drug (generics, IMDs) candidate selection and development (clinical trials, approvals)
Establish global sales and distribution network for synthetic pharmaceutical products
Production
Production

DS/DP Production Management
Manage biopharmaceutical production process control and conduct GMP documentation
Troubleshoot and improve production
Evaluate qualification of GMP facilities, laboratories and equipment

Production and Technical Support
Conduct production process management, validation, technical support and result analysis
Manage technology transfer of DS, DP, CMO and operate pilot lab
Monitor and improve process and quality

ENG/Validation
Manage plant designs and construction projects
Operate production facilities and conduct maintenance
Conduct validation of equipment, facility and system
Quality
Quality

Quality Assurance (QA)
Operate GMP quality system (documentation, training, deviations, changes, audits, etc.)
Review and approve GMP facilities, equipment, production processes, testing, packaging, logistics, etc.
Response to due diligence of regulatory agencies, internal audits, vendor evaluation and quality contract management

Quality Control (QC)
Conduct experiments of raw materials, DS and DP analysis
Monitor production facilities and utility
SCM
SCM

S&OP
Establish biologic DS·DP production plans, assess production and sales impact and manage inventory/order management
Establish sales plans, manage performance and forecast demands
Manage CMO contract and network

Procurement & Material Management
Manage import/export transportation and customs clearance management and conduct cold chain and AEO-related tasks
Set-up transportation plans and routes
Purchase and transport raw and subsidiary materials and manage inventory, supply and demand, and procurement management
Executive Management
Executive Management

Executive Management
Establish and coordinate company-wide business and work plans
Establish, plan and operate IT systems
Conduct PR/brand management and establish and operate IR strategies
Conduct HR management, recruitment and manage company culture

Finance
Conduct domestic and international financial/management accounting and fund management tasks
Operate internal accounting control system and respond to external audits

Legal & Intellectual Property
Conduct information security, compliance and ESG management
Manage domestic and international legal and intellectual property management
Sales & Marketing
Sales & Marketing

Biopharmaceutical Sales
Establish strategies for business development, new market entrance and overseas sales
Conduct various tasks related sales organization operations

Global Marketing
Develop global marketing strategies, conduct overseas market research and collect/analyze product sales data
Develop and execute P&R strategies