Kishore Reddy Email and 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.
Arthur Pharma
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Manager In Analytical Research And DevelopmentArthur Pharma Nov 2023 - Present𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔-✔Leading Analytical Method Development: Spearheading the development of robust analytical methods for pharmaceutical products, ensuring accuracy, reproducibility, and compliance with global regulatory standards.✔Overseeing Method Validation: Managing the validation of analytical methods, including assay and impurity profiling, to guarantee the reliability and consistency of data across various drug formulations.✔Coordinating Stability Studies: Directing stability studies and forced degradation tests, analyzing data to ensure product efficacy and safety over time, and preparing stability reports for regulatory submissions.✔Ensuring Regulatory Compliance: Ensuring adherence to cGMP guidelines and FDA regulations, overseeing the preparation of necessary documentation, and facilitating successful regulatory audits.✔Managing Analytical Instrumentation: Overseeing the operation, calibration, and maintenance of advanced analytical instruments, including HPLC, UPLC, and GC, to maintain optimal performance and data integrity.✔Supervising Documentation Processes: Supervising the preparation of detailed analytical reports, validation protocols, and method transfer documents, ensuring accuracy and compliance with regulatory requirements.✔Facilitating Method Transfers: Leading the transfer of validated methods from R&D to manufacturing sites, ensuring seamless integration and adherence to GMP standards.✔Driving Project Management: Driving the execution of R&D projects, from planning to completion, ensuring milestones are met on time, within scope, and aligned with strategic objectives.✔Collaborating with Cross-Functional Teams: Collaborating with quality control, regulatory affairs, and production teams to align analytical methods with product development goals and regulatory expectations.
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Deputy Manager - Analytical Research & DevelopmentSp Accure Labs Private Limited Aug 2022 - Oct 2023𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔-✔Led Analytical Method Development: Directed the development of analytical methods for both injectable and oral pharmaceutical products, ensuring they met stringent quality and regulatory standards.✔Managed Method Validation and Transfer: Oversaw the validation of analytical methods, including method transfer from R&D to production sites, to ensure consistent and reliable results across various stages of development.✔Supervised Stability and Degradation Studies: Coordinated and executed stability studies and forced degradation tests, analyzing data to confirm product stability and efficacy over time, and preparing comprehensive stability reports.✔Ensured Compliance with Regulatory Standards: Ensured adherence to cGMP guidelines and regulatory requirements, managing documentation and facilitating successful regulatory inspections and audits.✔Monitored Analytical Instrumentation: Managed the operation, calibration, and maintenance of advanced analytical instruments, including HPLC and UV-Vis Spectroscopy, to ensure optimal performance and accuracy.✔Directed Team and Project Management: Directed a team of scientists and managed multiple analytical research projects, ensuring timely completion, effective collaboration, and alignment with organizational objectives. -
ScientistEugia Pharma Specialities Ltd Jul 2015 - Aug 2022Hyderabad, Telangana, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔-✔Developed Analytical Methods: Developed and refined analytical methods for both injectable and oral dosage forms, ensuring that these methods were highly accurate and reliable for assessing the quality and efficacy of pharmaceutical products.✔Validated Analytical Techniques: Conducted thorough validation of analytical methods, including assay and impurity testing, to ensure compliance with regulatory standards and to guarantee consistent and reproducible results throughout the product lifecycle.✔Managed Stability Studies: Directed and managed stability studies and forced degradation tests, meticulously analyzing stability data to confirm the longevity and effectiveness of pharmaceutical products under various conditions.✔Ensured Compliance with Regulations: Ensured strict adherence to current Good Manufacturing Practice (cGMP) guidelines and other regulatory requirements, preparing comprehensive documentation for regulatory audits and submissions to maintain compliance and support product approval.✔Coordinated Method Transfers: Facilitated the seamless transfer of validated analytical methods from research and development phases to manufacturing sites.✔Supported Cross-Functional Collaboration and Addressed Inquiries: Worked closely with cross-functional teams, including quality control and regulatory affairs, to align analytical research strategies with broader development objectives and regulatory requirements. Managed and addressed US FDA and other market-related inquiries. -
ExecutiveCaplin Point Laboratories Ltd Jun 2014 - Jul 2015Chennai Area, India𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔-✔Developed Analytical Methods: Designed and validated analytical methods for injectable formulations, utilizing HPLC and other advanced techniques to ensure accurate and reliable results.✔Validated Analytical Procedures: Conducted comprehensive validation of analytical procedures, including assay and impurity testing, to meet regulatory standards and support product development.✔Performed Instrument Maintenance: Operated, calibrated, and maintained advanced analytical instruments, including HPLC and UV-Vis spectrophotometers, ensuring optimal performance and precision.✔Prepared Detailed Documentation: Compiled and reviewed detailed documentation, including validation protocols, method transfer reports, and analytical test results, ensuring accuracy and adherence to GMP standards.✔Supported Regulatory Submissions: Assisted in the preparation and submission of regulatory documents, including responses to queries and compliance reports, facilitating successful regulatory reviews and approvals. -
Junior Executive Ar&DEpsilon Pharmaceuticals May 2012 - May 2014𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔-✔Assisted and Analysed Analytical Methods: Assisted in the design and optimization of analytical methods for injectable pharmaceutical formulations, including assays, related substances, and residue analysis, utilizing HPLC and UPLC techniques.✔Performed Stability Testing: Executed stability studies for injectable products, analyzing data to determine shelf-life and product stability under various conditions.✔Managed Instrumentation: Operated and maintained advanced analytical instruments such as HPLC and UV-Vis spectrophotometers, ensuring proper calibration and performance.
Kishore Reddy Education Details
Frequently Asked Questions about Kishore Reddy
What company does Kishore Reddy work for?
Kishore Reddy works for Arthur Pharma
What is Kishore Reddy's role at the current company?
Kishore Reddy's current role is Manager in Analytical Research and Development @ Arthur Pharma ✦ Analytical Method Development ✦ Project Management ✦ Pharmacovigilance ✦ FDA Compliance & Documentation ✦ 10+ Years Exp ✦ Pharmaceutical Industry ✦.
What schools did Kishore Reddy attend?
Kishore Reddy attended Rajiv Gandhi University Of Health Sciences, Kakatiya University (University College Of Pharmaceutical Sciences).
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