Srinivas Rao C

Pharma/Biotech Consultant|

Consulting • Trabajador autónomo

Dec 2025 - Present • 7 mos

With nearly 26 years of distinguished expertise spanning drug substance production, formulation, filling, and packaging, offers elite regulatory and operational consulting services for global biopharmaceutical enterprises. Having risen through the ranks to senior leadership at premier organizations bridges the critical gap between complex cleanroom operations and uncompromising international statutory benchmarks.

Senior Manager

Biotech Hunter • Tiempo completo

Apr 2024 - Dec 2025 • 1 yr 8 mos

Formulation, Filling, Visual Inspection, and Packing operations across 3 production blocks at the plant, ensuring seamless vaccine manufacturing and timely commercial supply. Key Result Areas:  Spearheading formulation, filling, and packing operations, continuously optimizing end-to end vaccine production processes while maintaining strict quality and compliance standards.  Leading and mentoring a team of ~100 professionals, actively enhancing workforce productivity, engagement, and skill development to sustain high-performance operations.  Driving bulk manufacturing efficiency, implementing process improvements, and managing commercial production activities to ensure operational excellence and timely delivery of vaccines.  Administering the Quality Management System (QMS), maintaining training, documentation, and audit-ready practices in alignment with WHO, CDL, and Indian regulatory authorities.  Championing SAP adoption and digital transformation across manufacturing processes, improving workflow efficiency, data accuracy, and cross-functional collaboration.  Managing additional operational functions, including laundry services for production suites, ensuring timely provision of clean garments while staying hands-on in daily problem-solving and cross-department coordination. Highlights:  Enhanced vaccine production efficiency through optimization of formulation, filling, and packing processes while maintaining full compliance with WHO, CDL, and Indian regulatory standards.  Improved team productivity by mentoring and up skilling professionals, resulting in faster turnaround times and reduced operational bottlenecks. Oct’03 – Apr’24 | M/s Sanofi Healthcare India Pvt. Ltd., Hyderabad Rich & stable experience in healthcare operations and management, contributing over 20 years to company growth prior to management restructuring. As Senior Manager: Key Result Areas:  Directed formulation and filling operations as Suite In-charge

Sr Manager

Sanofi • Tiempo completo

Oct 2003 - Apr 2024 • 20 yrs 6 mos

As Senior Manager: Key Result Areas:  Directed formulation and filling operations as Suite In-charge at the Medchal plant, managing multiple manufacturing suites, streamlining suite operations, and ensuring cGMP and WHO compliance during routine operations and inspections.  Engineered maintenance, qualification, and requalification protocols for all formulation, filling, and packing equipment; supervised facility installation, documentation development, and external audits (WHO&GQA) to ensure operational reliability and regulatory adherence.  Authored and managed critical documentation, including BMR, LMR, BPR, SOPs, PP, and RSTs, maintaining full compliance with cGMP standards and WHO specifications.  Pioneered new formulation, filling, and packing lines for vaccines, including Influenza Type-B, taking projects from conceptualization to full-scale production; established antigen production processes for Diphtheria, Pertussis, Cholera whole cell, and Hemophilus vaccines.  Established and maintained Master and Working seed lots for Diphtheria and Pertussis antigens for the first time at Shantha prior to Sanofi, ensuring high-quality antigen production.  Orchestrated monthly production plans, coordinated raw material procurement, and optimized manufacturing efficiency while maintaining strict GMP compliance.  Led failure investigations, implemented Corrective and Preventive Actions (CAPA), and drove continuous process improvements across formulation, filling, and packing operations.  Mentored and trained newly recruited technicians and production staff, maintained GMP training records, and enhanced team capabilities to meet regulatory and operational standards.  Bridged Production and Controlling Departments for project design, budget planning, and execution for Product Costing; championed the implementation of Athena (SAP) as key user, representing FFP & Bulk Antigen Departments in the PP Module.  Administered industrial operati