Jun Ho Cho Email & Phone Number

대한민국 충청북도 청주시

Head of purification department• Overall supervision of the biosimilar and new drug purification process.• Collaboration with the R&D for process setup and development of clinical trial batch production and improvement of commercial production feasibility for development-stage products• Manage team leaders• Process fit analysis for potential client’s process• Review and approve batch records and SOPs (Standard Operating Procedures)• Review and approve deviation, CAPA and chane control• Monitoring the progress of production processes at the site, identifying potential risks and problem areas, and conducting process improvement activities.• Establishing procedures for monitoring process data and managing processes through trend investigations.• Establishing aseptic technique process for APBL’s DS filling operation and improvement plans.• Collaboration with the formulation department for DS and DP related activities• Establishment of production schedules• Department managment (Human resource, budget and etc.)• Identifying secondary and tertiary vendors to address raw material supply instability and improving existing materials.• Task Force atcitivy for cell culture contamination• Prepare and join regular Quality Coucil• Co-work with global client and consultants• Supervision of manufacturing and facility area• Activities to improve the production environment of the facility (piping improvements and proactive responses to hygienic issues)• SME for QP audit and MFDS (KFDA) inspection

대한민국 인천

MSAT, Tech Support• Set up operation procedures to implement tech transfer information received from clients at the purification site.• Initiating the procurement process for necessary items at the purification site.• Monitoring the progress of production processes at the site, identifying potential risks and problem areas, and conducting process improvement activities.• Investigating and reviewing deviations from a production department perspective.• Proposing CAPAs (Corrective and Preventive Actions) and developing phased plans from short-term to long-term perspectives.• Analyzing and integrating the use of formats across different factories in SBL• Conducting training for junior staff members.• Engaging in activities to prevent column contamination (equipment management and reviewing operational methods).

Incheon,Korea

Team Leader• Participating in the entire process from the construction phase of the facility to the production phase.• Production tasks from the biosimilar development run to the commercial run.• Establishing process operation parameters that align with the capacity of the facility's equipment and process machinery.• Set up process equipment, securing or purchasing raw materials, and preparing various GMP documents for manufacturing process.• Monitoring the progress of production processes at the site, identifying potential risks and problem areas, and conducting process improvement activities.• CMO production and internal production• Communication with CMO clients• Improvement activities to increase production yield.• Initiation and investigation deviations• Addressing abnormal situations and performing immediate action• Proposing Corrective and Preventive Actions (CAPA)• Checking the operation capability and status of equipment, monitoring the status of raw material procurement, and assessing the progress of relevant departments' tasks.• Establishing or improving aseptic procedures, process enhancements, retraining of workers, and acquiring necessary equipment and machinery for ISO5 and 7 areas during the DS (Drug Substance) production phase• Establishing procedures for proper management of paper output data to ensure data integrity.• SME of inspection for FDA, EMA, PMDA, as well as countries in regions like Australia, Brazil, Russia, Southeast Asia, West Asia, and African countries.• Handling 483 letters• Auditor for overseas raw material suppliers

대한민국 인천

Shift Supervisor• Performing key processes such as Chromatography, Ultrafiltration/Diafiltration (UFDF), Virus filtration, Final filtration, and Buffer preparation.• Participating in the process from the construction phase of the facility to the production phase.• CMO production and internal production• Communication with CMO clients• Handling the procurement of various equipment and machinery.• Production tasks from the biosimilar development run to the commercial run.• Performing tasks from FAT (Factory Acceptance Test) to validation and test runs.• Set up process equipment, securing or purchasing raw materials, and preparing various GMP documents for manufacturing process.• Write and review SOP, MBR.• Initiate and deviation, CAPA and chage control.• Day and night shift supervisor