Jack Han Email & Phone Number

1.Be responsible for the construction of QC lab of the company's commercial base, deeply involved in the QC area layout, drawing review, room design (electricity, network and gas) and the whole process of laboratory and stainless steel furniture suppliers selection . The laboratory had completed the overall reception and put into use.2.Be charge of the investigation, installation, Qualification and Metrology Management of Instrument and Equipment, including CE, HPLC, TOC, UV, insoluble particle meter, Osmo, electronic balance, pH meter, etc. Familiar with the draft and review of URS, RA, IOQ, PQ, RTM and VSR 3. Take part in the establishment of the document system of the commercial base, including but not limited to the whole process of the establishment of standard management documents (STP), Standard operation specifications (SOP), analytical methods (GAM), product/raw/auxiliary package quality standards and inspection procedures.4.Be Responsible for laboratory operation, instrument, and physical and chemical team building, including personnel recruitment, training and daily work arrangement.5.Participate in the method transfer of plasmid, drug substance and drug product, familiar with the whole method transfer process and establish physical and chemical, raw and excipient materials and utility systems that meet commercial production requirements involves analytical methods and validation and evaluation of the methods to meet plant requirements.6. Take plant utility system validation, including but not limited to process water, pure steam, process gas scheme review and daily release test, the work has been completed.

1. Led the quality control department following the principles of lead &l earn, coaches and develops employees, and performs employee development review utilizing the MAG system.2, Ensuredd that quality control of all starting materials, packing materials, and the analysis for complaint samples.3. Be responsible for documentation and release procedures for all starting materials, packing materials, analytical transfers for new product launch. Ensure QC activities meet the requirements of relevant national laws, GMP regulations and instructions or guidelines of Boehringer Ingelheim.4. Ensured a safe work environment for all staffs. Maintains safe and adequate storage of chemicals, solvents, reference substances, consumables, microorganisms cultures, and spare parts. Ensures adequate controls for a reliable systems.5. Assured that all required sampling and tests are conducted, the retention samples are managed properly. The adequate validation or verification for analytical methods are fulfilled, the analytical method transfers for new products, the stability studies for products are implemented.

Shanghai City, China

1. Be responsible for raw material testing, sampling and sample management;2. Establish GMP manufacturer QC raw material lab including instrument purchase and instrument qualification, quality document writing, personnel recruitment, internal training system and quality system establishment and lab operation management;3. Have solid theory and hands-on experience of analytical method. Lead the team establishing the method development, method verification, method transfer and validation process.4. Build lab risk assessment to monitor and control the lab quality risk and event. And be familiar with manufacturer quality events procedure including CC, OOS, DV and CAPA;5. As a QC functional leader, participate in clinical DS and DP project management to promote relevant QC testingand release running smoothly in manufacturer.6. Extensive experience in team management. The team number increase from 4 to 18 in 2020 and raised 3 sub-group leaders, establish a complete training, quality control and performance evaluation system. Awarded as ''Outstanding staff” in 2019 annual performance review;7. Be responsible for the reception and question answering of the external audits. In 2019, participated in 20 + external 8. Establish the lab operation system. In 2019, 100% of the laboratories passed 5S star certification and safety aboratory certification. One lab was awarded "Group 5S star lab”and I was awarded “All-around excellence award” in completion activities of QC & AS department;9. Be familiar with the quality standard declaration requirements of raw materials and excipients in different countries;10. Lead a across-department cooperation costing saving lean sigma green belt project. The project was completed successful, the cost saving was about 73% compared to previous date. The GB project was awarded "Excellent Green Belt Project

中国 上海市区

Assist lab head to manage USP Verification program and Third party testing projects . Commit to compliance with GMP and EHS requirements. Be responsible for dietary substance, dietary supplement, drug substance and drug product release test, Notebook review and final report preparation. Details as follow:Responsibilities as follows:1.Be responsible for USP-China VER department daily management work, prepare testing plan and schedule lab work to ensure task completed within timeframe.2.Be ability to effectively multi-task/manage multiple parallel projects.3.Familiar with USP and ICH guideline for drug substance and drug product’s method development and validation.4.Hands on experience in drug substances, drug product (Injection and tablet) and dietary supplement (Soft gels, capsule, tablets and gummies) analytical support and release test. 5.Document test data, test results and reports in comply with documents standards. Ensure all analytical results and documentation is of high quality, generated in a timely fashion, and complies with GMP regulations.6.Familiar with application of analytical instruments (HPLC, GC, GC-HS, IC, IR, UV, ICP-MS, dissolution and disintegration, etc).7.Pursue, recommend, and implement new approaches or processes to improve laboratory efficiency. 8.Participate to the evaluation and purchase of new analytical instruments and consumables.9.As EHS committee member, be responsible for project EHS inspection and acceptance procedure.10.As observer follow GMP audit manager to audit the dietary supplement factory.

中国 上海市区

Assist analytical director to manage the external analytical projects. Support medical chemistry research projects, the work area cover HPLC and LCMS method development, routine tests, prep-HPLC purification and structure elucidation.1.As a group leader, responsible for arrangement, coordination and communication of daily work; promptly identify and resolve problems.2.Manage multiple projects simultaneously, participate project discussion, help to solve analytical issues, provide technical consultation.3.Draft analytical contracts, prepare and review analytical project reports.4.Familiar with application of analytical instruments such as HPLC, LC-MS, GC, GC-MS, Prep-HPLC and NMR. Have strong data and spectra analysis capabilities. 5.Familiar with instrument daily maintenance including analyzing and trouble-shooting problems, identifying solutions, recommending and implementing methods, procedures and techniques for resolution. 6.Recruit and train new analytical scientists7. As coach and mentor to direct and coordinate the work of staff.

中国 河北 石家庄

Mainly engaged in R&D center liquid crystal materials as analyst to perform analytical methoddevelopment and routine inspection of sample. 1.Support R&D department and solve problems in plant. 2.Develop methods for known or unknown compounds in process control and carry out structure identification by GCMS.3.Familiar with application of GC-MS, HPLC, GC, DSC, Digital Melting Point, etc. 4.Maintain and repair lab instruments.5.Attend quality management system (GB/T19001-2000) training, and obtain the certificate.