Kishore Reddy Email & Phone Number

🔬 𝐀𝐬𝐬𝐢𝐬𝐭𝐚𝐧𝐭 𝐌𝐚𝐧𝐚𝐠𝐞𝐫 𝐢𝐧 𝐀𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐚𝐧𝐝 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 | 𝐀𝐫𝐭𝐡𝐮𝐫 𝐏𝐡𝐚𝐫𝐦𝐚🧪 Analytical Method Development | Project Management | Pharmacovigilance📜 FDA Compliance & Documentation | 10+ Years Experience in the Pharmaceutical IndustryWith over a decade of experience in the pharmaceutical industry, I currently work as an Assistant Manager in Analytical Research and Development at Arthur Pharma. I have a solid background in Pharmaceutics, Good Laboratory Practice (GLP), Oncology, Validation, and GMP compliance, consistently delivering excellence in pharmaceutical projects.💡 𝐊𝐞𝐲 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞:► Developed and validated analytical methods for assays, related substances, and residue analysis using HPLC & UPLC for oncology injectables and solid dosage forms, including lyophilized powders and liquid injections.► Extensive experience in Analytical Method Validation and supporting validation activities in Quality Control (QC) for pharmaceutical formulations.► Skilled in performing Method Verifications of APIs and conducting feasibility studies.► Proficient in using advanced analytical instruments such as HPLC, UV-Vis Spectrophotometers, and KF Titration for drug analysis.► Conducted HPLC analysis for stress, stability, and in-process samples, adhering to global pharmacopoeias like USP, BP, and EP.► Managed Stability Studies and Forced Degradation Studies, ensuring compliance with regulatory standards.► Expertise in handling deviations, out-of-specifications, and ensuring seamless ANDA validation per regulatory requirements.📋 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 & 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧:► Prepared and updated specifications, standard test procedures, and stability data for FDA audits and cGMP documentation.► Led the Analytical Method Transfer from R&D to GMP-compliant manufacturing sites.► Assisted in regulatory audits and ensured adherence to FDA and other global regulatory standards.► Addressed regulatory agency queries with precise, analytical reports and conducted initial reviews of project documents.With a strong focus on ensuring regulatory compliance and optimizing analytical methodologies, I thrive in fast-paced environments and contribute to the successful delivery of high-quality pharmaceutical products.Connect with me to get the detailed exposure in analytical method development, validation, and regulatory compliance for oncology and injectable formulations.