Kishore Reddy Email & Phone Number

Hyderabad, In

𝑲𝒆𝒚 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.

𝑲𝒆𝒚 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.

Hyderabad, Telangana, India

𝑲𝒆𝒚 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.

Chennai Area, India

𝑲𝒆𝒚 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.

𝑲𝒆𝒚 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.

M.Pharmacy, Pharmacology

B. Pharm