Pioneering Scientific Excellence
Dr. Mst Sharmin Aktar brings a wealth of expertise in analytical chemistry, structural biology, and pharmaceutical formulation, ensuring precision, innovation, and regulatory excellence in every project. Her skill set spans advanced analytical techniques, protein characterization, and drug development, contributing to breakthrough scientific advancements.
Core Competencies Overview
Advanced Analytical Method Development & Validation
Expert in developing, validating, and optimizing analytical methods using HPLC (Empower, ChemStation), UV-Vis spectroscopy, FTIR, and Karl Fischer titration to ensure accuracy, reproducibility, and regulatory compliance. Proficient in troubleshooting analytical challenges, optimizing method conditions, and implementing process improvements to enhance laboratory efficiency. Skilled in supporting stability studies, method transfer from R&D to QC, and ensuring data integrity in GMP-regulated environments to meet regulatory expectations.
Formulation Development
Expert in designing, developing, and optimizing solid dosage formulations to ensure stability, bioavailability, and regulatory compliance. Proficient in troubleshooting formulation challenges, optimizing process conditions, and maintaining product integrity in GMP-regulated environments. Skilled in supporting NDA/ANDA submissions, scale-up processes, and technology transfer to enhance pharmaceutical product efficacy. Experienced in collaborating with cross-functional teams to streamline formulation strategies and regulatory alignment.
Protein Purification & Structural Characterization
Expert in developing and optimizing chromatography-based protocols for protein purification and characterization. Skilled in designing and troubleshooting analytical methods using UV-Vis spectroscopy and HPLC to ensure accuracy and reproducibility. Obtained and analyzed five novel protein X-ray crystal structures, accepted into the RCSB Protein Data Bank, contributing to advancements in structural biology research. Experienced in conducting complex data analysis and preparing scientific publications.
Quality Management Systems (QMS) & Regulatory Compliance
Experienced in overseeing and ensuring compliance with Quality Management Systems (QMS) in GMP-regulated environments, aligning with cGMP, FDA, and ICH guidelines. Proficient in implementing process improvements, conducting audits, and ensuring data integrity to enhance laboratory operations. Skilled in regulatory documentation, deviation investigations, and CAPA implementation, supporting method validation, stability studies, and regulatory submissions to uphold industry standards and product quality.
Technical Skills Overview
Analytical Method Development
Developing and validating precise analytical methods to ensure accurate and reliable results in compliance with regulatory standards.
Pharmaceutical Drug Product Development
Designing and optimizing formulations for stable and effective pharmaceutical products, ensuring safety and efficacy.
Protein Purification and Characterization
Utilizing advanced techniques to isolate and analyze protein structures for pharmaceutical and scientific applications.
Process Flow Documentation, DoE, SOPs, GLP, GMP, IPC
Implementing robust documentation processes to streamline workflows and maintain compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Experimental Design and Development
Crafting robust experimental protocols to generate reliable data and drive innovative research outcomes.
Protein Separation and Purity Assessment
Ensuring high-quality protein samples through meticulous separation and purity testing techniques.
Problem-Solving and Troubleshooting
Resolving complex technical issues in analytical processes and formulation development to enhance operational efficiency and accuracy.
Regulatory Submission and Audits (FDA, MHRA)
Preparing and managing documentation to support successful regulatory submissions and audits in alignment with FDA and MHRA requirements.
DNA Sequence Analysis and PCR
Applying molecular biology techniques to analyze DNA sequences and perform precise PCR assays.
Strong Understanding of Advanced Laboratory Techniques
Proficient in operating and managing advanced instruments and techniques for reliable experimental results.
Cross-Functional Team Leadership and Collaboration
Facilitating seamless communication and coordination among teams to drive project success and innovation.
Bacterial Cell Culture
Culturing bacterial cells for experimental and biotechnological applications with a focus on quality and reproducibility.
Mentorship and Training
Guiding and empowering junior scientists to enhance team productivity and foster a culture of learning.
Strong Verbal and Written Communication Skills
Effectively presenting scientific data and findings through compelling reports, presentations, and discussions.
Interpersonal Ability to Work Effectively as Part of a Team
Collaborating with diverse teams to achieve shared objectives and drive innovative solutions.
Instrumental Skills Overview
High-Performance Liquid Chromatography (HPLC)
Proficient in using HPLC systems, including Empower and ChemStation, for accurate separation and quantification of complex compounds.
UV-Visible Spectroscopy
Skilled in using UV-Vis spectroscopy for detailed qualitative and quantitative analysis of chemical and biological samples.
X-ray Crystallography
Specialized in solving protein structures using advanced X-ray crystallography techniques, contributing to drug discovery and structural biology.
Gas Chromatography (GC)
Experienced in employing GC techniques for the characterization of volatile and semi-volatile compounds in analytical research.
Fluorescence Spectroscopy
Expert in conducting fluorescence-based analyses to investigate molecular interactions and enzymatic processes.
Fourier-Transform Infrared Spectroscopy (FTIR)
Proficient in FTIR for structural identification and functional group analysis of diverse compounds.
Dissolution Testers
Experienced with Distek dissolution testers for evaluating drug release profiles in pharmaceutical formulations.
Karl Fischer Titration
Proficient in using Karl Fischer titration for precise moisture content analysis in raw materials and finished products.
Advanced Laboratory Instrument Maintenance
Skilled in calibrating, troubleshooting, and maintaining laboratory equipment to ensure accuracy and compliance with regulatory standards.