Formulation R&D Supervisor

Responsible for guiding method development, validation, release testing and stability studies in the quality research of innovative drugs, and ultimately establishing quality specifications.

In charge of drafting and reviewing various project documents, and timely handling deviations arising during quality research.

Responsible for drafting and reviewing pharmaceutical analysis-related application materials and raw records, accurately and clearly presenting quality research content to meet regulatory submission requirements and complete drug registration applications.

Conduct literature retrieval in both Chinese and English, and keep track of the latest updates on domestic and international regulations as well as research progress.

Reasonably arrange workload for each project; promptly propose solutions to analytical technical issues to ensure steady project progress.

Undertake daily management of the analytical laboratory and provide professional training for analysts.

Complete other tasks assigned by the management.

Major in Pharmaceutical Formulation, Pharmacy or related disciplines; PhD or Master’s degree with more than 2 years of working experience in innovative formulation R&D.

Familiar with cGMP, ICH, FDA and other R&D technical guidelines, as well as domestic and international registration, application and review requirements.

Proficient in operating analytical instruments such as moisture analyzer, dissolution tester, HPLC and LC-MS; capable of independently conducting analytical method development and validation.

Well-versed in technologies related to formulations and dosage forms of various administration routes. Possess comprehensive R&D and project management experience in biopharmaceuticals and chemical drugs, including pre-formulation study, preclinical dosing formulation development, formulation prescription & process research, and process scale-up.

Proficient in retrieving and reading professional English literature, with solid English writing skills and the ability to compile English regulatory application documents.

Strong time management and execution capabilities, able to arrange and drive the progress of multiple projects simultaneously.