- Improve yield rates of stem cells; develop and apply platform stem cell technologies
- Optimize culture process for mass production; oversee technology transfer
- Develop analysis methods; conduct clinical analysis (K and immunogenicity analysis method development and CRO management)
- Evaluate conformity and equivalence; identify and analyze product characteristics; prepare approval documents
- Plan, manage, and conduct animal tests and toxicity tests for new drugs, biosimilars, and cosmetic ingredients
- Secure platform technologies; develop and adopt animal testing models for flagship new drugs
- Establish, plan, and manage R&D strategies
- Manage development progress; evaluate development feasibility
- Establish approval strategies for biopharmaceuticals (biosimilars ∙ new antibodies); negotiate with regulators
- Manage and update national regulatory requirements and guidelines; register products and conduct follow-up management (change control)
- Oversee global clinical trial operations (IND application, patient recruitment, and CRO management)
- Maintain and improve clinical trial quality (clinical trial provider monitoring, etc.)
- Plan global clinical trials for biopharmaceuticals (biosimilars and new antibodies) and develop clinical trial protocols
- Analyze clinical trial results; prepare trial reports; handle inquiries from approval authorities; prepare approval documents
- Manage pharmaceutical safety information during clinical trial phases; report to regulators
- Build and manage local pharmacovigilance systems according to national pharmacovigilance regulations (anomaly identification, preparation, and reporting of safety documents)
- Build and manage pharmacovigilance quality systems
- Build and manage clinical ∙ nonclinical test quality systems
Clinical Statistics
- Statistical analysis for clinical trial design
- Analyze clinical data and post-approval data
- Statistical analysis for approvals; handle inquiries from regulators
CMC Statistics
- Statistical analysis for R&D and new drug projects
- Statistical analysis for process development
- Statistical analysis for approvals; respond to inquiries from regulators
Data Management-Medical
- Review case reform form (CRF) designs
- Plan and carry out clinical data management; classify and review medical data codes
Data Management-System
- Develop and manage electronic data collection (EDC) system
- Manage clinical test data and data quality
Drug Product (DP)
- Manage biopharmaceutical production processes
- Handle production issue troubleshooting; improve production practices
- Handle good management practice (GMP) documents
- Manage production processes; provide technical support for process validation; analyze validation results
- Oversee technology transfers and operate pilot labs
- Evaluate the conformity of GMP, lab equipment, and facilities
- Manage production processes; provide technical support for process validation; analyze validation results
- Oversee technology transfers (DS ∙ DP ∙ CMO) and operate pilot labs
- Conduct process ∙ quality monitoring; identify risks; carry out improvements
- Manage DS, DP, and packaging CMO contracts and networks
- Operate and manage CMO manufacturing sites; analyze process data trends
- Plan long ∙ medium-term production ∙ supply; monitor plant operation
- Forecast and manage ingredient inventory
- Manage CMO supply and procurement
- Manage the inventory of active pharmaceutical ingredients (APIs) and finished products
- Manage international transportation ∙ customs clearance; handle cold chains and authorized economic operators (AEOs)
- Operate GMP quality systems (documents, training, deviation, change, audit, etc.)
- Review and approve GMP facilities, equipment, processes, tests, packaging, and logistics
- Handle due diligence by regulators; manage internal audits, supplier evaluations, and quality contracts
- Draw scientific conclusions from the analysis of materials, APIs, and finished products (microbiological tests, physicochemical tests, process monitoring tests, release tests, and transfer of testing technologies)
- Conduct and mange biological assays
- Analyze and test stability; validate testing equipment
- Design bio ∙ pharmaceutical plants (APIs ∙ finished product production facilities)
- Manage bio ∙ pharmaceutical plant construction projects
- Operate clean ∙ black utilities
- Operate automated systems
- Handle energy ∙ environmental operations
- Validate equipment ∙ facilities ∙ computer systems (IQ, OQ, PQ)
- Handle due diligence by regulators and customers
- Select and develop (clinical trial ∙ approval) synthetic products (generic, IMDs)
- Build global sales networks for small molecule products
- Manage the life cycles of biopharmaceuticals
- Develop business plans; manage revenue and profit·loss
- Handle and manage product development projects
- Assist with clinical trials; manage global clinical supply networks
- Monitor markets, identify new products, develop strategies to build portfolios, and manage the life cycles of commercialized products
- Handle issues at subsidiaries; oversee consolidated financial statements
- Handle tax reports (corporate tax, VAT, etc.); review tax issues and handle affairs with related authorities
- Manage revenues ∙ expenditures and funds; analyze performance
- Handle HR management and development
- Monitor patents, survey existing trademarks, apply for trademarks, develop brand names, and secure rights for biosimilars and generic products
- Plan responses to, and manage IP disputes and other legal disputes and actions
- Manage legal risks and provide compliance support
- Prevent, respond to, and manage legal disputes
- Review contract issues and other legal issues
