mainly responsible for all the formulation development related work for IND submission. drug products under developing include 1 general IR film coated tablet, 1 IR tablet based on ASD technical using spray drying method, and 1 IR capsule. Till now, 2 of these INDs have been authorized for clinical trials in Austria, two IR tablets; and 3 INDs has been submitted to NMPA for the application of phase I clinical trials, IR capsule got approval for clinical trials. Review and compilation of 32p and 23p CTD dossier in Chinese and English, formulation development protocol and report, GMP manufacturing related documents. Troubleshooting and communication with CROs on the formulation development technicals.

Totally experienced 5 projects, namely IR tablet and capsules and Lyo-injection, covering phase I and Pivotal Phase II stage, mainly focusing on the development, optimization, tech transfer, manufacturing related activities based on scientific, QBD and risk assessment, life time cycle management concept using knowledge management as an enabler. Manage project management, e.g. organizing cross-functional team meeting, following up the progress of actions agreed during meeting, contract negotiation, signing , tracking deliverables in agreed critical millstones, closing stage work and paying to third party and so on.

-Lead multiply projects - Full product development( lab trials, scale-up, process validation / Exhibit batches manufacturing, transferes, safety assessment, filter validation, packaging compatibility study ) for localization of tablets , capsules, Lyo, TS Liquid Injection products from global marketed of Hetero Drugs Limited, India- Process improvement and technical transfer of licensing in product.- Project leader of multiply projects, coordinate cross-functional team( internal & external) to achieve key projects deliveries as per timelines;-Work with india team and local cross- functional team to ensure category strategy, project, priority and resources are well aligned and delivered- Provide technical support for troubling shooting and product improvement of marketed product. - Budget management for R&D localization products- Complete 3 products( 2 lyo and 1 capsule) development and transfer from R&D to manufacutre site, - Lab management leader for FR&D-Familiar with guildines and regulatory released by CFDA, FDA ,ICH guildines

Responsible for API imported registration (India API), familiar with current guildine and regulatory; translating, compiling submission dossier(EN-CN); Communicating with India counterpart on China drug regulatory and techinical related issues ; Making registraion plan, strategies.Oversea training programesInvolved in 1M oversea training programes( india, Hetero drugs limited); visited the advanced FDA, EMA compliance GMP facilities, and accepted an comprehensive, advanced and current FDA EMA compliance GMP management concept training; focus on QA management training.

Focus on Oral Solid Dosage development, generic drug (class 6) and class 3 new drug submission , including IR tablets and capusle, MR tablets; Leading OSD project development and transfer activies, from information/ literature invertigation, Lab trial, scale-up batch, process validation batches manufacuturing activieites, Submission dossier(CTD format) and related record, protocol and report compiling, to on-site inspection; responsible for conducting MR tablet quality consistent study with Innovators; clinial study batches manufacturing; Familiar with the current guildines and regulatory.Good communicate skills with R&D and Facilities personnels; Skillful in Wet granulation, direct compression, capsule filling, FBD and so on OSD development techinicals;