Danh Nguyễn Lê Trọng Email & Phone Number

Ho Chi Minh City, Vietnam

Binh Duong, Vietnam

- Led and managed an analytical team, ensuring successful project execution and adherence to regulatory standards, and timely delivery.- Spearheaded the development and validation of analytical methods for remediation projects, including high potency drug products.- Ensured compliance with industry regulations (e.g., EMA, ICH) and implemented best practices in the analytical laboratory.- Specialized in the development and validation of dissolution profiles for bioequivalence studies, contributing to regulatory submissions and approvals.- Conducted analytical development projects, with dissolution profiles for bioequivalence assessments.- Played a key role in successful regulatory submissions, including remediation projects and export projects.- Contributed to the successful submission in local and export.- Played a pivotal role in supporting inspections by coordinating analytical documentations regarding finished products and APIs, responding to inquiries, and ensuring compliance.- Collaborated with cross-functional teams to support product development, troubleshoot analytical issues, and ensure project milestones were met.- Negotiating with suppliers has consistently resulted in securing favorable deals and competitive pricing for new equipment and services.- Provided leadership in CAPEX and OPEX budgeting processes, optimizing resource allocation and achieving cost efficiencies.

Binh Duong, Vietnam

- Conducted analytical research to support drug development projects, focusing on HPLC, UV, IR.- Collaborated with R&D teams to analyze samples, and interpret results for decision-making.- Actively participated in cross-functional project teams and contributed to the successful completion of remediation projects.- Ensured compliance with industry regulations (e.g., EMA, ICH) and maintained high-quality standards in the analytical laboratory.- Conducted dissolution profiles for bioequivalence studies.

Binh Duong, Vietnam

- Conducted routine and non-routine analyses of raw materials, in-process samples, and finished products including assay, impurity, dissolution, using analytical techniques such as HPLC, UV, IR, and Karl Fisher.- Performed method validation and verification to ensure accuracy and reliability of test results.- Collaborated with cross-functional teams to investigate and resolve deviations, out-of-specification results, and other quality-related issues.- Maintained and calibrated analytical instruments, ensuring their proper functioning and accuracy.- Contributed to the development and optimization of analytical methods, enhancing efficiency in quality control processes.- Executed stability studies to assess the shelf life and quality of products over time.