Manoj Kumar
Sr Executive
Hire their services
Request a quote with no obligation
About
- 9 years of industrial experience in New Product Development, technology transfer, Scale-up, and troubleshooting & Manufacturing of nonclinical and clinical dosage forms for the Regulated market.
Experience
Design and conduct pre- formulation, formulation, process, stability, and container closure development studies for drug products. Demonstrate sound knowledge in wet granulation, fuid bed dryer, extrusion- spheroidization, fuid bed (Wurster) coating processes and MUPS technology. Execute scale- up of drug product processes to enhance effciency and production quality.
Prepare professional technical reports, presentations, and Chemistry, Manufacturing, and Controls (CMC) documents for regulatory submissions. Manage manufacture of scale-up batches to meet project timelines and quality standards. Collaborate with cross- functional teams to ensure adherence to regulatory requirements.
Optimize formulation processes to improve drug product performance. Maintain up- to-date knowledge of industry regulations and best practices in drug development.
Education
- Audit Management and quality management system (QMS) Dec 2022 - Dec 2022 .
- Design of Experiment (DOE) Systech, Technology service pvt.ltd Nov 2022 - Nov 2022
