Job Information
Job Description
R&D
Production
Quality
Production Strategy
Management Strategy
Management Strategy
Human Resources & General Affairs
- HR planning
- General affairs and labor
- Purchase management
- Welfare
Management Strategy
Financial Accounting
- Fund management
- Financial accounting
- Tax accounting
- Cost accounting
Management Strategy
System Operation
- IT planning, operation, project management
- In-house infrastructure and software maintenance
- CSV (Computer System Validation)
- Information protection
- Laboratory system (computerized analysis equipment) management
Production Strategy
EHS
- Environmental management
- Industrial health
- Industrial safety
Production Management
Process Development
- Optimization of the process
- QbD-based process research
- Domestic and overseas CMC preparation
- Scale up/pilot test
- Transfer of on-site technology
- Manufacturing technology efficiency/Troubleshooting
Production Strategy
Production Management
- Raw material inventory management and forecast
- Establishment and sales of Active Pharmaceutical Ingredients, production plan, inventory management
- Building and operating a production management system
- Maintenance for the continuity of effective production
Production Strategy
Quality Engineering
- Equipment & Facility Qualification & Maintenance
- HVAC & Clean Room Environment Test
- Instrument Calibration
Production
Peptide Synthesis
- Production of peptide products (synthesis, purification, freeze-drying)
- Document management in accordance with cGMP regulations
- Small size peptide product Test
Production
Bio-clean Room
- Sterile Cephalosporin APIs Production
- Document management in accordance with cGMP regulations
- Preventive maintenance of equipment
Production
Non-Cepha
- General APIs Production
- Document management in accordance with cGMP regulations
- Standardized production process management
- Risk Based Process Safety Management (RBPS) activities
Production
Cepha
- Cephalosporin APIs Production
- Document management in accordance with cGMP regulations
- Standardized production process management
- Risk Based Process Safety Management (RBPS) activities
Quality
Analysis Approval
- Establishment of approval strategy, preparation of CTD documents and registration approval
- Test method development and validation
- Forced degradation test
- Consignment of cGMP-based analysis work and technical support
Quality
Quality Control
- Determination of product compatibility and safety test
- Manufacturing management through interim process inspection
- cGMP Quality Policy Operation
Quality
Quality Assurance
- Quality Operation
- Quality Management System
- Validation
- Quality Compliance
R&D
Synthesis Research
- Development of oligonucleotide
- Development of peptide, PEG linker, PEGylation
- Purification of bio-based active pharmaceutical ingredients
- Development of active pharmaceutical ingredient (API)
- On-site process development
- Preparation of CTD data
R&D
Analytical Research
- Analytical method development by A-QbD
- Research for Impurity profile and reference standard
- Genotoxic impurity study and in-silico study
- Preparation of CTD data
R&D
New Business Planning
- Explore the latest technologies in the field of biotechnology
- Research on key raw materials related to mRNA
- New capping materials and modified NTP research
R&D
CDMO
- CDMO work coordination
- Domestic and overseas CDMO business
- Conduct cooperative work with overseas big pharma
- Preparation of CTD data
R&D
Technical Sales
- Japan-specific Active Pharmaceutical Ingredients and sales of new technology development
R&D
공정개발
- 공정 최적화 및 현장화 기술이전
- QbD 기반 공정연구
- 국내외 CMC준비
- Scale up/pilot test
- 제조기술 효율화/Troubleshooting