Dr. Sharmin Work Experience

✅Method Development and Validation: Spearheaded the development, validation, and troubleshooting of analytical methods for characterizing drug substances and products using HPLC & UV/Vis spectrophotometry, ensuring compliance with cGMP, FDA, and ICH guidelines.

✅Formulation Development Oversight: Led the formulation team to design, develop, and optimize drug formulations, aligning with project timelines and regulatory standards.

✅Quality Assurance and QMS Oversight: Monitored and ensured compliance with Quality Management Systems (QMS), implementing process improvements to enhance laboratory operations.

✅Data Analysis and Reporting: Authored detailed technical reports and reviewed analytical data to support regulatory submissions and maintain data integrity.

✅Collaboration: Partnered with cross-functional teams, including formulation and manufacturing, to streamline workflows and support product scale-up.

✅Mentorship: Trained and mentored junior scientists, fostering technical skill development and improving team productivity by 30%.

✅Innovative Problem-Solving: Implemented analytical solutions and process optimizations that enhanced laboratory efficiency by 20%, improving overall data accuracy.

✅ Analytical Testing: Conducted in-process control, release, and stability testing of drug substances, ensuring accuracy and compliance with cGMP guidelines.

✅Method Validation Support: Refined standard operating procedures (SOPs) and qualification protocols, enhancing operational efficiency and supporting method validation efforts.

✅Troubleshooting Expertise: Assisted in resolving analytical method challenges, ensuring reliable and reproducible results in a fast-paced GMP-regulated environment.

✅ Protein Purification and Characterization: Developed and optimized chromatography-based protocols, successfully purifying proteins and characterizing their structure and function.

✅ Analytical Method Development: Designed and troubleshot analytical methods using UV-Vis spectroscopy and HPLC, ensuring accuracy and reproducibility of results.

✅ Structural Biology: Obtained and analyzed five novel protein X-ray crystal structures, accepted into the RCSB Protein Data Bank, contributing to scientific advancements.

✅Data Analysis and Reporting: Conducted complex data analysis and authored publications in peer-reviewed journals, showcasing strong scientific writing and problem-solving skills.

✅Scientific Data Presentation: Skilled in presenting scientific data and results effectively in both written formats (technical reports, publications) and oral formats (presentations, conferences, and team discussions), tailored to diverse audiences.

✅Mentorship and Training: Guided graduate and undergraduate researchers in experimental techniques, fostering technical skill development and laboratory efficiency.

✅Formulation Development: Developed NDA/ANDA solid dosage formulations, ensuring compliance with FDA, MHRA, and global standards. Achieved a 20% improvement in submission success rates and enhanced process efficiency through team collaboration.

✅Analytical Method Development: Designed and validated HPLC method for solid dosage formulations, ensuring adherence to FDA, MHRA, and ICH regulatory standards.
✅Regulatory Compliance: Played a key role in successful NDA/ANDA regulatory submissions, increasing approval rates by 20% through meticulous documentation and adherence to global standards.

✅Troubleshooting Expertise: Addressed formulation and process-related challenges using data-driven problem-solving approaches, improving product stability and performance.

✅Technology Transfer: Managed scale-up and technology transfer from lab-scale to manufacturing, ensuring seamless integration and strict compliance with cGMP guidelines.