QbD-Driven HPLC Method Development - Design Expert -13 software

I am currently pursuing a PhD in Medical and Health Sciences and require an experienced expert in Analytical Quality by Design (AQbD), Design of Experiments (DoE), and Design-Expert 13 to assist with a retrospective QbD implementation for my HPLC analytical method. There are 3 combination of Drugs that needs to be back tracked . My HPLC method has already been successfully developed and optimized. However, an AQbD objective was introduced during the course of my PhD, and I now need to retrospectively construct the complete QbD framework around my existing method. This is not a new method development project—I need someone who can scientifically backtrack the development process and present it in a manner that is academically rigorous, technically sound, and suitable for inclusion in a PhD thesis. The scope of work includes: Reviewing my finalized HPLC method. Identifying the Critical Method Parameters (CMPs) and Critical Quality Attributes (CQAs). Developing an appropriate AQbD strategy using Design-Expert 13. Designing and justifying the DoE (preferably Box-Behnken or another suitable design, if scientifically justified). Assisting with experimental design, statistical analysis, ANOVA, response surface methodology, optimization, and establishment of the analytical design space. Ensuring the entire workflow aligns with ICH Q14, ICH Q2(R2), USP <1220>, and current AQbD principles. Producing documentation and explanations that are suitable for publication-quality research, PhD thesis submission, and viva defense. I am looking for someone with proven expertise in pharmaceutical analytical method development, AQbD, chemometrics, and Design-Expert 13, who can help reconstruct the QbD workflow around an already established method while maintaining complete scientific integrity and academic defensibility.

Project ID: 40617337