Job Description

• I successfully developed and improved analytical methods for new drug formulations, ensuring compliance with industry standards.
• -New analytical method of organic impurity Diphenidol Hydrochloride (In house method) and organic impurity Cephadol 25mg film-coated tablets (In house method)
• -Development analytical of Diphenidol Hydrochloride assay with potentiometric titration method (development from JP18 pharmacopeia)
• -Development analytical of Diphenidol Hydrochloride impurity with Gradient method of HPLC (development from JP18 pharmacopeia)
• -Development analytical of Cephadol 25mg assay with Isocratic method of HPLC (development from JP18 pharmacopeia)
• -Development analytical of Cephadol 25mg impurity with Gradient method of HPLC (development from JP18 pharmacopeia)
• -Development analytical of Relative retention factor (RRF) of Diphenidol HCl and Cephadol 25mg tablets for impurity factor to truly %w/w of qualitative product and transfers to routine analysis.

Job Description

• I successfully developed and improved analytical methods for new drug formulations, ensuring compliance with industry standards.
• -Developed analytical methods for new drug formulations, including Lercanidipine 20mg and Dapagliflozin 10mg tablets.
• -Designed dissolution profiles based on USP, BP, and EP guidelines, enhancing drug solubility.
• -Conducted dissolution profile comparisons with ICH guidelines and Nonlinear Optimization Algorithm (Bootstrap f2 method, Multivariate confidence region etc.) to meet Biowaiver requirements, enhancing drug formulation.
• -Analyzed quality control of pharmaceutical products during trial batch processes, ensuring compliance with laboratory standards.
• -Improved analytical methods in line with ICH guidelines, facilitating smoother transitions to routine laboratory use.
• I successfully developed and improved of new drug (In house method without another official monograph)
• -New analytical method of Lercanidipine 20mg tablets (In house method) Including assay, dissolution, Impurity and dissolution profiles.
• -New analytical method of Dapagliflozin 10mg tablets (In house method) Including assay, dissolution, Impurity and dissolution profiles.
• Example manufacturing optimization (pre-formulation) of pharmaceutical product
• -Atorvastatin 10, 20, 40 and 80mg tablets
• -Celecoxib 200 and 400mg capsules
• -Sitagliptin 50, 100mg tablets
• -Sildenafil 20, 50, 100mg tablets
• -Rivaroxaban 10, 20mg tablets, Etc.

Job Description

• Section A. - QA (Quality Assurance)
• -Training and human resource development to have basic knowledge that follow up to work context under company structure. Example the lab routine, RD and Method Validation.
• -The support center of the everyone in the company and solve problems and intro the right way to solve the problem.
• -The update of new knowledge of chemical analytical to the laboratory team.
• Section B. - RD (Research and Development)
• -To develop the analytical method of new company product that co-project with GENSIGN company, Especially the hormone drug group (Levonorgestrel and Finasteride project)
• -The compare with the similarities (F2) and the difference (F1) under dissolution profiles requirements that terms the Biowaiver to objective the improvement of drug formulation.
• -To develop the chemical analytical methods based on USP, BP or EP pharmacopeia and the ASEAN guideline and to comply with the equipment Laboratory instruments and this is correct according to laboratory standard.
• -Improvement of chemical analytical methods based on ICH guideline and transfer method to routine laboratory.
• Section C. - MV (Method Validation)
• -Design and writing for validation of analytical method (protocol/report) in according to a current ICH guideline and for new dosage form that published in current USP pharmacopeia.
• -To improvement the correctness of the method validation with refer to drug product formulation.
• -To update method validation to be the presently pharmacopeia and transfer method to routine laboratory.

Job Description

• Responsibilities:
• -Develop analytical methods for the quality control of active ingredients and pharmaceutical products in trial batch (pre-process manufacturing).
• -Design and writing for validation of analytical method (protocol/report) in according to a current ICH guideline and for new dosage form that published in current USP pharmacopeia.
• -Responsible analyze to quality control of pharmaceutical product in manufacturing pilot (Lab scale and production scale).
• -Responsible following to a stability study of pharmaceutical products corresponding to the ASEAN guideline.
• Achievement:
• -Prepared validation and verification protocols/reports for various pharmaceutical products, ensuring compliance with industry standards.
• -Conducted rigorous testing for accuracy, precision, and robustness of qualitative drugs under validation methods.
• -Oversaw quality control in the manufacturing of pilot pharmaceutical products, including Lab scale and production scale.