Raj Kumar Sharma

About Raj Kumar Sharma

Strategic and results-oriented Pharmaceutical Executive with over 25 years of leadership experience in drug development, regulatory affairs, manufacturing and quality assurance operations. Proven track record of driving innovation, leading cross-functional teams, and delivering regulatory success across global markets. Adept at aligning technical operations with corporate strategy, optimizing processes, and mentoring high-performing teams to achieve business objectives in dynamic environments.Core Competencies• Pharmaceutical Product Development• Regulatory Strategy & Submissions• Manufacturing and System Controls• Technology Transfer & Scale-Up• Process Optimization & Validation• Cross-Functional Leadership• Strategic Planning & Execution• Capital Project Management• Team Development & Mentorship

Experience

1. Senior Pharmceutical Technology Scientist

   Rhodes Pharmaceuticals

   May 2016 — Present · Coventry, RI, US

   Sr. Pharmaceutical Technology Scientist – Key Responsibilities & Achievements• Sr. Pharmaceutical Technology Scientist – Key Responsibilities & Achievements• Managed Qualification and Lifecycle of Commercial Products at CMO Sites: Oversaw technical operations for 15+ commercialized products across 5+ global CMO sites, ensuring consistent product quality and compliance with FDA and Health Canada standards.• Led Technology Transfer and Scale-Up Projects: Directed 10+ successful technology transfers, optimizing processes based on CMO capabilities. Achieved 30% reduction in scale-up timelines through proactive planning and equipment alignment.• Formulation Development and DOE Execution: Led formulation development for 8+ new drug products, applying DOE strategies using Minitab and JMP. Improved formulation robustness, resulting in 20–40% reduction in batch failures during scale-up and validation.• Regulatory Submission Support: Contributed to 12+ ANDA submissions, with 100% first-cycle acceptance rate for technical sections. Played a key role in responding to FDA and Health Canada IRs/CRLs, helping secure approvals with average response time under 30 days.• Documentation and Compliance Excellence: Authored, reviewed, and approved 100+ GMP documents, including Master Batch Records, Packaging Instructions, SOPs, and Protocols. Ensured audit readiness and supported 3 successful regulatory inspections with zero critical observations.

Education

• Panjab University

  Bachelor, Chemical Engineering

  1988 — 1992

Skills

• Manufacturing
• Lean Manufacturing
• Capa
• Continuous Improvement
• Pharmaceutical Industry
• Sop
• Fda
• V&V
• Process Simulation
• Environmental Monitoring
• Technology Transfer
• Technical Writing
• Formulation
• Validation
• Cross-Functional Team Leadership
• Chemical Engineering
• Six Sigma
• Chemistry
• Process Engineering
• Gmp