RAJKUMAR YERRMSHETTI

Seasoned, results-driven professional with 18+ years of extensive experience in API and CRAMS manufacturing, scale-up, new product validations, production, and project management. Demonstrated expertise in technology transfer, productivity enhancement, and cGMP-compliant operations. Proficient in conducting process safety assessments, including HIRA and HAZOP studies, and implementing operational optimizations. Known for strong leadership, effective cross-functional collaboration, and exceptional analytical skills, with a proven record of accomplishment of delivering consistent, scalable, and compliant processes.

• Excellence Award for Best Productivity Initiative – Dr. Reddy’s Laboratories.
• Appreciation letter for productivity improvement – Vasant Chemicals Ltd.
• Recognized for driving process stabilization and scale-up efficiency at multiple organizations.

• 18+ years of experience in pharmaceutical manufacturing and operations, with strong exposure to API, intermediates, and key raw material production.
• Proven expertise in New Product Validations, Production Management, Operations Management, Strategic Planning, and Project Management.
• Deep knowledge of regulatory requirements, quality systems, and compliance standards applicable to pharmaceutical manufacturing.
• Strong leadership and people management skills, with the ability to lead and mentor large teams to ensure efficient and effective plant operations.
• Advanced analytical and problem-solving abilities, adept at identifying quality issues, analyzing data, and implementing CAPA to close gaps and strengthen product quality.
• Excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams and clear reporting to stakeholders.
• A strong continuous improvement mind-set, consistently driving enhancements in operational performance, process robustness, and customer satisfaction.
• Skilled across kilo-scale, pilot-scale, and commercial-scale manufacturing, with hands-on experience in technology transfer, scale-up techniques, and accelerated process improvement at the R&D stage.
• Extensive involvement in process validation, cleaning validation, and facility qualification activities.
• Expert in handling regulatory and customer audit remediations, investigations, RCA, and impact assessments.
• Strong capability to lead cultural transformation initiatives, promoting operational excellence and compliance-focused behaviours.
• Demonstrated strength in managing OPEX and CAPEX related to manufacturing operations with a focus on cost optimization and resource utilization.
• Proven experience in de-bottlenecking and capacity enhancement, enabling better plant utilization and improved throughput.