Kao Lu P.

Senior Scientist @ Foresee Pharmaceuticals

About

R&D Manager / Senior Investigator with 9+ years of experience in drug formulation development. Expert in formulation and process development of generic drugs under QbD and ICH guidelines, with hands-on experience across multiple dosage forms, including sustained-release injectables, lyophilized vials, prefilled syringes, ophthalmic suspensions, and oral tablets.

Country

Taiwan

City

Hsinchu Metropolitan Area

Industry

Biotechnology

Skill

Project Management, Drug formulation, 專案規劃, 團隊管理, 研究與開發 (R&D), 研究, 產品開發, 生物科技, 資料分析, 專案管理, 製藥工業, 生命科學,  cGMP process development and manufacturing., LC-MS/MS, Establishment of drug screening platform, Protein expression (E coil, insect-baculovirous, lentirvirus expression), Untargeted metabolomics data analysis strategies using LC-MS/MS and LC-TOF

Experience

Senior Scientist

Foresee Pharmaceuticals

2024-8 - Present · 2 yrs 2 mos

台北市

Developed 505(b)(2) sustained-release injectable formulation and supported scale-up under cGMP.

Manager, Formulation Research Division

SLC BioPharm.

2020-1 - 2024-7 · 4 yrs 7 mos

台灣 Taiwan 苗栗縣

Responsible for leading the R&D team in formulation development under QbD and ICH guidelines, ensuring on-time delivery of project milestones. Authored and prepared CMC documents (CTD 3.2.P). Conducted evaluation and development of generic and 505(b)(2) drugs, including patent assessment, formulation design, and process optimization. Prepared and proven track record in developing and tech-transferring multiple dosage forms, including sterile injectables, ophthalmics, and oral solid formulations.

Senior Investigator

Savior Lifetec Corporation

2016-6 - 2019-12 · 3 yrs 7 mos

Miaoli, Taiwan

Led formulation development of sustained-release nanoparticles and lyophilized injection, completing pre-clinical studies, CMC documentation, and achieving stability comparable to or exceeding RLDs. Conducted project evaluations including patent FTO analysis, process optimization, and cost/timeline assessment.

Postdoctoral Fellow, National Institute of Environmental Health Sciences

National Health Research Institutes

2011-9 - 2016-6 · 4 yrs 10 mos

Miaoli, Taiwan

Executed Ministry of Science & Technology and TFDA projects, applying high-resolution mass spectrometry with cell and animal models to characterize xenobiotic metabolites. Established LC-TOF and LC-MS/MS metabolomics platforms for lung and oral cancer research related to xenobiotic exposure. Successfully identified xenobiotic metabolites and evaluated their potential as biomarkers.