Md Mahmud Alam

Senior Assistant Analytical Development Manager

Eskayef Pharmaceuticals Ltd.

02.2017 - 07.2024

Company Overview: (US FDA, UK MHRA, EU GMP Approved)
Instrumental Method Development and Troubleshooting: Have ability to operate and troubleshoot the instruments and developed analytical methods in instruments such as HPLC, Gas Chromatography, AAS, Inductive Coupled Plasma Optical Emission Spectrometry (ICPOES), Other instruments.
Method Development: Developed Analytical method such as assay and dissolution method of either USP/BP grade or INN grade material and experimental batches of different type of doses form.
Method Validation: Have excellent experience about impurity method validation analyzing all validation parameters and also preparation of protocols and reports.
Team Leadership: Have smooth experiences of leadership and working as a team leader, taking care of a bunch of different products with excellent capability of workload handling and employee development.
Stability studies: Initial and Stability studies of experimental batches and report submission.
Took responsibilities of Oncology, Hormonal, MDI and DPI Projects that includes more than 20 individual molecules.
Experienced in both product and raw material related analysis, their method development and troubleshooting, documentation and reporting.
Source approval: Source approval and method development of USP, BP and INN grade materials.
Calibration: Calibration and documentation of laboratory instruments like HPLC, UV, Dissolution tester, stability chambers and other instruments.
Maintaining, arranging and communicating regularly with supplier and commercial officers to arrange all documents, CRSes, Reagents, HPLC columns to continue analysis smoothly.
Following GLP according to FDA, TGA and UK MHRA requirements.
Assisting to prepare the laboratory and to face US FDA and UK MHRA audits.
To Monitor and assure the laboratory reagent management for smooth analysis as well as for GLP.
To monitor and assure all types of internal laboratory requisition time to time for smooth running of laboratory works.
To prepare Product and raw material Control Direction and SOPs.
To prepare and standardize working standards and analytical reagents according to compendia maintaining proper labeling, storage condition and traceable documents.