Job Description
Product Formulation and Development Design and development of new pharmaceutical product formulations and optimization of existing formulations.
Selection and evaluation of technically suitable raw materials, excipients and suppliers.
Conducting pre-formulation studies and checking the compatibility of raw materials and excipients.
Preparing laboratory samples and conducting necessary tests to select the optimal formulation.
Investigating and resolving formulation, stability, solubility, uniformity, viscosity, appearance and other physicochemical properties.
Designing and implementing stability studies in product development stages.
Preparing and documenting formulations, manufacturing methods and product development reports.
Collaboration in scale-up, formulation transfer and process transfer to production.
Analysis and development of laboratory methods Development, optimization and review of product and raw material analysis methods.
Development and optimization of assay, related substances/impurities and dissolution methods if applicable.
Investigating chromatography problems, identifying interfering peaks and optimizing analysis conditions.
Review and evaluate pharmacopoeial methods and authoritative references and adapt them to the product.
Prepare standard and sample solutions and conduct laboratory studies with accuracy and appropriate documentation.
Cooperate with QC in Analytical Method Transfer and resolve method problems.
Documentation and inter-unit cooperation in preparing protocols, research and development reports, formulation development reports, and analytical study reports.
Prepare and update technical documentation required for product registration in cooperation with the regulatory unit.
Cooperate with QC, QA, production, and regulatory departments in product development and transfer projects.
Scientific and technical review of problems encountered in production and provide corrective solutions.
Study scientific sources, pharmacopoeias, articles, and patents, and apply relevant information in R&D projects.
Professional, process-oriented, and result-oriented spirit
