Luis Lu Email & Phone Number

Melrose Park, Il, Us

New York, New York, Us

Lake Zurich, Illinois, Us

Somerset, Nj, Us

Validation life cycle

Chicago, Us

Expansion Project in RadioPharmaceutical products:Facility Qualification: FAT, SAT and IOQUtility: Purified Water System and HVACEnvironmental: Chambers, Autoclaves, Depyrogenation Ovens and Walk-ins CoolersSoftware: Building Monitoring SystemDocumentation: Users Requirements, Risk Assessments and Trace Matrix.

Mumbai, In

Qualified the Oral Solid Dosage (OSD) manufacturing and packaging line equipment, not limited to PLC, HMI and computer system associated with manufacturing processWrote/executed validation protocols and final reports.Initiated deviation, discrepancy reports, memorandum and non compliance issues.

South San Francisco, California, Us

Lead Cell Culture Project 2 (CCP2) equipment qualification of downstream processCommissioning and Qualification Prepared/executed protocols and final reportsEvaluate System Impact Analysis (SIA), Critical Impact Analysis (CIA) and Equipment Gap Assessments

Melbourne, Victoria, Au

Developed/ Validated the manufacturing mixing homogeneity for Bioreactor tanks from 2,000-Liters to 10,000-Liters.Developed/validated temperature mapping during mixing.Developed/validated process validation in plasma fractionation protein and albumin platform.Prepared/executed protocols for mixing studies, discrepancy reports and summary reports.Qualified manufacturing equipment IQ, OQ and PQ.

Developed and validated the manufacturing process.Qualified the manufacturing equipment, complies to FDA CFR21 Part 11.Evaluated/ Validated mixing homogeneity for Bioreactor tanks

Conducted cancer drugs development programs, and demonstrated strong technical and leadership experiences in pharmaceutical developmental cycle from preclinical.Supported the Regulatory Affair Agency for filing (ANDA/NDA) submission. Reviewed the scientific data in formulation study batches, method development/validation in analytical, quality control, and physical testing to ensure complying to Quality System prior submitting to Regulatory Affair Agency.

Lake Zurich, Illinois, Us

Conducted the method development and method cleaning validation in analytical methods. Developed and validated HPLC methods in chromatographic Assay and Impurity complied with ICH and USP guidelines. Evaluated the process validation of Abraxis products before and after manufacturing. Verified/tested Empower software for clients/servers application by using manual and automated procedures.Performed Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) for laboratory equipments used such as HPLC, GC and LACE boxes.Performed a technical review and audited internal laboratory notebooks, data packages and technical reports from product development (R&D) and Quality Control (QC) Complied to Quality System, Regulatory, FDA and ICH guidelines.

Performed Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) for Blood Gas Analyzer.Developed the Dialysis medical device membranes for Regeneration of Peritoneal Dialysis solution. . Performed both small and large scale in-vitro and vivo experiments to understand the performance of medical devices.

Abbott Park, Illinois, Us

Prepared study protocols in solution mixture of each experiment to understand the homogenous mixing in dynamic tests of clinical required. Prepared SOPs, protocols and technical reports in mixing processes validation.Characterized mixing studies.Equipments used: HPLC, Mass Spectrometer, Conductivity Meters and Tachometers.

Master Degree- In Progress, Chemistry

B.S, Chemistry

Bachelor, Chemistry