Company Name:Arthur PharmaTitle:Manager in Analytical Research & Development.Location:ChinaTime Period:Since Nov’23Responsibilities:• Spearheaded the development of advanced analytical methods utilizing HPLC and UPLC techniques, demonstrating proficiency in achieving precise assay determination and identification of related substances and residues.• Engaged in a wide range of oncology injectable and solid projects, encompassing diverse formulations such as lyophilized powders and liquid injections, showcasing versatility in addressing varied analytical challenges across different drug delivery systems.• Led the planning and execution of method validation activities within the Quality Control (QC) department, overseeing validation protocols, execution, and documentation to meet regulatory compliance standards.• Collaborated closely with cross-functional teams, including R&D, Regulatory Affairs, and Manufacturing, to facilitate seamless technology transfer of analytical methods and support product lifecycle management initiatives.• Initiated and drove continuous improvement initiatives aimed at enhancing method development and validation practices, leveraging data-driven insights and best practices to drive efficiencies and quality enhancements.• Ensured adherence to regulatory guidelines and standards in all method development and validation activities, proactively addressing compliance issues and preparing the QC department for successful regulatory audits.

Company Name:Orbicular pharmaceutical Technologies Pvt. Ltd.Title:Sr. Research Scientist in Complex Injectable AR&DLocation:HyderabadTime Period:Jan’17-Sep’23Responsibilities:• Managed a team of 8 Scientists, overseeing day-to-day operations and leading complex Injectable projects from development to successful ANDA filing.• Reviewed and approved SOPs, guidelines, and change control documents, providing training on compliance procedures.• Conducted method validation and analysis using HPLC and GC for various formulations, including Microspheres.• Oversaw documentation review and approval processes, ensuring timely release of analytical reports and technical documentation.• Coordinated with external contract manufacturing organizations and testing labs to maintain quality standards and timelines.

Company Name:Eugia Pharmaceutical Specialties Ltd.Title:Research Associate in Injectable AR&DLocation:HyderabadTime Period:May’15-Jan’17Responsibilities:• Developed HPLC and UPLC methods for assay, related substances, and residue analysis for Oncology injectable and solid projects, including Lyophilized Powders and Liquid Injections.• Oversaw technology transfer of analytical methods to Quality Control Lab for finished products and raw materials.• Conducted stability studies in accordance with cGMP regulations and prepared method development reports and standard test procedures for finished products.• Managed investigation and closure of incidents, deviations, and change controls.

worked as Analytical method development scientist.

Analytical Method developments for Assay, Related substances in Oral solution,Wet Analysis in regular lab activities,Calibration activity in wet lab instruments.

worked as Research Associate, Analytical Method development for Assay, Related substances and Dissolutions.Analytical method validations,compatability studies,pre formulation studies.