Teams & Roles
Teams & Roles
CAREERS
Management Support
Overview
The management support team supports HL Genomics’ stable operations and sustained growth by overseeing accounting, finance, human resources, and general affairs. It ensures financial transparency and stability through accurate financial reporting, tax compliance, and treasury management.
In addition, the team manages key administrative functions including recruitment, labor relations, asset oversight, and facility management and supports corporate governance through legal affairs and the coordination of Board and Shareholders’ meetings.
Strategic Business
Overview
The strategic business team drives HL Genomics’ mid-to-long-term growth in the API and pharmaceutical raw materials business. Beyond traditional sales and procurement. It develops and implements integrated business strategies to respond to the evolving global regulatory requirements and market demands.
Its scope encompasses the entire business cycle: from market analysis, forecasting simulations, and sales strategy development to client relationship management, ensuring a stable supply of raw materials, and overseeing import/export logistics. We also manage GMP-compliant quality and regulatory documentation and maintain systemic data through ERP management.
In the pharmaceutical sector, supply chain stability and regulatory compliance are critical to a company’s competitiveness. Accordingly, the Strategic Business Team plays a pivotal role in ensuring supply chain resilience and quality-driven business management.
Production Support
Overview
The Production Support Team is a vital unit that ensures seamless manufacturing operations by managing the material handling lifecycle in strict compliance with GMP regulations. Our core responsibilities include inbound and outbound logistics, precise weighing(dispensing), and comprehensive warehouse management.
Warehouse and dispensing personnel oversee the secure storage and release of raw materials, packaging materials, and finished products. The team ensure that raw materials are accurately weighed and dispensed in accordance with the production schedule, enabling uninterrupted and efficient manufacturing operations.
Technical Support
Overview
The Technical Support Team is a pivotal department dedicated to HL Genomics’ sustainable growth and operational stability. It provides integrated management of technical support and EHS, covering equipment and process technology, environmental protection, and occupational health.
By complying with global standards and local regulations, the team ensures a safe and reliable manufacturing environment through proactive risk management and continuous improvement.
1. Engineering & Technical Support
- Technical review, operational management, and improvement of production facilities and utility systems.
- Safety evaluations and technical reviews for new equipment installation, expansion, or modification.
- Providing technical support and troubleshooting to ensure process stability.
- Enhancing energy efficiency and optimizing facility performance.
2. Environmental Management
- Managing environmental permits and ensuring adherence to relevant laws.
- Monitoring and managing environmental impacts related to air, water, waste, and chemical substances.
- Establishing proactive prevention systems and eco-friendly operational frameworks.
- Continuous monitoring and reporting of environmental performance.
3. Safety & Health
- Establishing and operating internal safety and health standards in compliance with occupational laws.
- Conducting workplace risk assessments and building robust safety management systems.
- Fostering a safety-first culture through regular training, education, and accident prevention programs.
- Developing emergency response frameworks and managing post-incident protocols.
4. Compliance & System Management
- Managing internal EHS regulations, SOPs, and integrated management systems.
- Supporting internal inspections and responding to external regulatory audits.
- Maintaining alignment with ISO, GMP, and other international quality standards.
- Managing company-wide EHS performance and driving improvement projects.
Manufacturing
Overview
The Manufacturing Team is dedicated to the safe and efficient production of Active Pharmaceutical Ingredients (APIs), the core components of medicine.In full compliance with GMP regulations, it manufactures a diverse range of APIs in accordance with standardized procedures and Batch Production Records (BPR).
Our production capabilities span from small-scale batches for clinical trials to large-scale commercial manufacturing. Our production capabilities span from small-scale batches for clinical trials to large-scale commercial manufacturing. It plays a critical role in ensuring the highest quality of APIs through seamless and close collaboration with all related departments.
Quality Control (QC)
Overview
The Quality Control (QC) team specializes in rigorous testing and verification to ensure that all raw materials, intermediates, and finished products meet defined quality specifications. It conducts chemical, physical, and microbiological analyses in compliance with GMP standards to ensure the safety, efficacy, and consistency of our products.
The team ensures the quality of APIs through scientific testing, including analytical method validation, raw materials and packaging materials testing, in-process control (IPC) testing, stability testing, and environmental monitoring. It manages all results using a data-driven approach to meet global quality standards required by regulatory agencies, including the MFDS, FDA, and EMA.
Quality Assurance (QA)
Overview
The Quality Assurance (QA) Team is a core department dedicated to guaranteeing the quality and safety of synthetic APIs throughout the entire production and release process. By adhering to domestic and international GMP regulations, we ensure the highest level of product reliability and deliver certified pharmaceuticals that our customers can trust.
[Key Responsibilities]
1) Quality System Management : Management of GMP documentation and establishment/revision of Standard Operating Procedures (SOP)
Oversight of Deviation management, CAPA (Corrective and Preventive Action), and Change Control systems.
2) Product Quality Assurance : Thorough review and approval of manufacturing processes and quality testing data.
Final authorization for finished product release (Batch Release).
3) Internal & External Audits : Continuous improvement of quality systems through regular Self-Audits.
Professional response to regulatory Inspections (e.g., MFDS and other international agencies).
4) Regulatory Affairs : Management of new product registrations and regulatory lifecycle/change management.
Data Integrity (DI)
Overview
The Data integrity (DI) Team is responsible for ensuring that all data generated during pharmaceutical manufacturing, testing, and quality control remains accurate, consistent, and complete. Operating under the fundamental ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available), It manages the entire Data lifecycle - from initial creation and review to approval and long-term archiving.
Our oversight extends from traditional paper-based records to advanced computerized systems, including QMS, EDMS, ERP, and CDS. By clearly defining roles and responsibilities and conducting rigorous internal audits and training, the team ensures that all employees maintain data integrity awareness and competency in compliance with global regulatory requirements.
R&D
Overview
The R&D Team is the engine of technical innovation at HL Genomics, specializing in process optimization, the stabilization of starting material supply chains, and the development of key intermediates. We manage the core technical pillars of our CMO & CDMO business, including project feasibility reviews, intensive research, and seamless technology transfers.
In close collaboration with our research labs, production units, and quality departments, we conduct comprehensive synthetic research for both existing and new products. Our expertise extends across the entire development spectrum—from initial synthesis and Pilot-scale studies to Process Validation (PV)—ensuring the robust and scalable production of high-quality APIs.
Synthesis Research Lab
Overview
The Synthesis Research Lab conducts new drug development in collaboration with the Development Department, New Product Research Lab, and New Drug Research Lab within the R&D Center, while also developing Active Pharmaceutical Ingredients (APIs) for Incrementally Modified Drugs (IMDs) and generic pharmaceuticals. The lab is strategically organized into two specialized units: the Synthesis Laboratory and the Safety Research Laboratory.
The Synthesis Laboratory performs synthesis research for new drug candidates, process development for generic APIs, and the synthesis of impurity standards. It also handles process optimization and pilot-scale production for the commercialization of developed products, while establishing robust solutions for potential technical challenges that may arise during commercial-scale production.
The Safety Research Laboratory is responsible for developing analytical methods for new drug candidates, IMDs, and generic APIs. It conducts in-depth research on impurities, including genotoxic and elemental impurities, and provides comprehensive analytical support for synthesis research. Additionally, the unit conducts stability studies for intermediates and APIs and prepares Common Technical Document (CTD) dossiers for domestic and international regulatory approvals.