Sanjeev Kumar Aavula

About Sanjeev Kumar Aavula

Success-driven, result-oriented professional with 20+ years of progressive experience in chemical process research and development, process validation and commercialization of active pharmaceutical ingredient (API) design for both generic and innovative molecules and product lifecycle management, training and leadership, coupled with proven track record of success in building and leading high-performing teams to deliver exponential growth and profitability. Expertise in drug substance development, including route design, process design, process characterization and optimization, design space (design of experiment), and control strategies. Dedicated and motivational leader who stimulates teams and encourages exceptional performance. Specialize in advancing highly effective new product development, process validation, and technology transfer programs for generic APIs and innovative NCEs, from concept to scale-up production. Successfully led projects throughout the entire API lifecycle, from early phase supply to the development of intricate Quality by Design (QbD) control strategies for validation, commercialization file, and launch. Proven track record in building quality systems, cGMP compliance, QbD systems, regulatory documentation & support, deficiency responses, risk management, validation, and technology transfer. Experience in CMC (Chemistry, manufacturing and controls) documentation sections of APIs. Contributed to authoring CTD modules to support regulatory submissions (IND through NDA). Expertise in evaluating the potential risk of contamination with genotoxic compounds in APIs and drug substances. Collaborated with project teams to establish effective control strategies. Experience overseeing diverse teams, improving quality and cost efficiency to boost competitiveness and revenue, ultimately maximizing the company\'s value. Pre-Sales, Lead generation and Business Development for Drug substances, related intermediates and new chemical entities for the regulated and non-regulated markets. Specialties: Technical development of APIs (generic and innovative molecules)| Synthetic Organic Chemistry | Process Chemistry | Technical transfer | GMP-manufacturing | Quality by Design (QbD), Design space (NOR, PAR)| CMC Documentation | Regulatory Support | Risk identification and mitigation | Genotoxic risk assessment (GRA)| Project Management | Team building | People development | Client Management | Pre-sales | Change management.

Experience

1. Director, Process Research & Development (Prd)

   Chemveda Life Sciences India

   Apr 2023 — Present · Hyderabad, IN

Education

• National Institute of Technology Surat

  Phd, Organic Chemistry