Han Gil Jung

1. QC Analyst Large Molecule

• Specialized in Cell based Bioassays and Separation (cIEF, LC-MS) tests for biological products.
• Participated in overall troubleshooting and investigation.

2. Analytical Method Transfer

• Implementation of the LC-MS testing method.
• Managed and executed analytical method transfers/co-validation.
• Reviewed method transfer protocols, and drafted final reports.
• Technical troubleshooting in collaboration with R&D and J&J internal labs.
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3. Compendial Method SME

• Served as the main contact point for issues/actions related/needed for the compendial method.
• Reviewed monthly compendia updates and assessed the impact of the change and initiated change when needed.
• Monitored the performance of compendial methods and initiated change when needed.
• Documented Laboratory issues for compendial methods in QMS.
• Participated and provided support as SME during inspections: FDA, MFDS, Internal audits (JJRC).

4. Training and Qualification SME

• Planned OJT for new personnel.
• Oversaw analyst qualification and re-qualification
• Continuous improvement to automate the Analyst Qualification process in LMS.
• Led a lean project to eliminate irrelevant document training in LMS.
• Participated and provided support as SME during inspections: FDA, MFDS, Internal audits (JJRC).

5. Investigation Owner

• Handled and documented NC, OOS/OOT, Lab Quality issues and CAPA records.
• Communicated and coordinated with cross functions for investigation.
• Participated and provided support during inspections: FDA, MFDS, Internal audits (JJRC).

6. LM Hub Safety Lead

• Served as the safety Hub Lead for all J&J Large Molecule quality labs.
• Led monthly meetings to discuss and share incidents/good saves that occurred across all J&J large molecule labs.
• Brainstormed ideas during monthly meetings with other J&J large molecule labs for safety improvement.
• Reported the outcome of the monthly meetings to the safety lead and presented the best good save to the leadership team.

• Performed laboratory testing to meet all timelines and deadlines for product release.
• Operated analytical instruments including HPLC, UV, Karl Fischer titrator, IR, Dissolution Apparatus, and ACL Top.
• Conducted tests such as Assay, Impurities, Dissolution, Water Determination, TLC, SDS-PAGE, Cell Culture, Coagulation Parallel Line Bioassay, and Endotoxin.
• Maintained all data and records in compliance with cGMP requirements and quality procedures.
• Reviewed test methods and regulatory documents in accordance with product registration changes.
• Completed an analytical method transfer from the manufacturing site in support of a new test method.
• Developed and revised SOPs.

• Performed physical and analytical tests to determine the nutritional content of raw and in-process materials used in infant formula manufacturing.
• Conducted various tests in accordance with USP requirements, utilizing instruments such as ICP-MS, GC, NIR, and Flash Protein Analyzer.
• Optimized testing cycle time by collecting and analyzing data to support model development for Near Infrared Spectroscopy (NIR).
• Cross-trained in multiple laboratories to assist during peak periods.
• Developed and revised SOPs.