Open To Work
Naresh Kumar Arnipalli
Work Preference
Summary
Senior Process Engineer with over 7 years of experience in API Manufacturing and CDMO operations, specializing in Technology Transfer, Process Scale-up, Process Optimization, Validation, Operational Excellence, and Commercial Manufacturing. Proven track record of successfully delivering 12+ technology transfer projects, supporting 15+ engineering and commercial batches, delivering measurable improvements in process efficiency, manufacturing cost, product quality, and plant productivity while ensuring GMP compliance. reducing manufacturing costs, and ensuring GMP compliance. Experienced in process optimization for complex unit operations including Grignard reactions, Hydrogenation, Distillation, Crystallization, Filtration, Drying, Solvent Recovery, Milling, and Compaction. Strong expertise in cross-functional collaboration with R&D, Production, QA, QC, Engineering, Automation, and EHS teams to deliver safe, efficient, and commercially successful manufacturing processes.
Overview
8
8
years of professional experience
Work History
Senior Engineer
Matrix Pharma Corp.
06.2023 - Current
- Lead end-to-end technology transfer from R&D to pilot plant and commercial manufacturing for API products, ensuring consistency in quality and yield.
- Execute process scale-up from lab to plant scale, addressing challenges related to mixing, heat transfer, and reaction kinetics.
- Provide hands-on support for reactor operations, optimizing reaction parameters such as temperature, pressure, and time.
- Managed New Product Introduction (NPI) activities, conducting feasibility assessments, defining processes, and ensuring manufacturing readiness.
- Troubleshoot process issues impacting yield, reaction performance, and product quality using data-driven approaches.
- Enhanced downstream processing (crystallization, filtration, drying) to improve purity, particle size distribution, and product stability.
- Led risk assessments and change management for process modifications and scale-up initiatives, ensuring regulatory compliance and operational efficiency.
- Develop and review PFDs, P&IDs, and process documentation for new and modified processes.
- Optimize utilities and solvent recovery systems, reducing operational costs while ensuring environmental compliance.
- Present technical data, scale-up reports, and process performance insights to internal stakeholders.
Associate
Eisai Pharmaceuticals India Pvt. Ltd.
10.2018 - 06.2023
- Lead end-to-end technology transfer from R&D to pilot plant and commercial manufacturing for API products, ensuring consistency in quality and yield.
- Manage New Product Introduction (NPI) activities, including feasibility assessment, process definition, and manufacturing readiness.
- Execute process scale-up from lab to plant scale, addressing challenges related to mixing, heat transfer, and reaction kinetics.
- Support process validation and engineering batches, ensuring compliance with GMP and regulatory expectations.
- Provide hands-on support for reactor operations, optimizing reaction parameters such as temperature, pressure, and time.
- Troubleshot process issues impacting yield, reaction performance, and product quality using data-driven approaches.
- Improved downstream processing (crystallization, filtration, drying) to enhance purity, particle size distribution, and product stability.
- Led risk assessments and change management for process modifications and scale-up initiatives.
- Optimize utilities and solvent recovery systems, reducing operational costs while ensuring environmental compliance.
Education
Bachelor of Technology - Chemical Engineering
Jawaharlal Nehru Technological University
Kakinada01-2018
Diploma - Chemical Engineering
State Board of Technical Education & Training
Andhra Pradesh01-2014
Skills
- Technology Transfer & Scale-Up
- R&D to Commercial Manufacturing Transfer
- New Product Introduction
- Process validation
- API Process Engineering
- Reaction Engineering & Reactor Operations
- Troubleshooting analysis
- Process optimization
- PFD development
- Process Chemistry & Reaction Kinetics
- Mass and Heat Transfer Optimization
- Crystallization
- Filtration & Drying
- Reaction kinetics
- Equipment selection
- Equipment Selection & Process Design
- Solvent Recovery & Cost Reduction
- Manufacturing transfer
Professional Highlights
- 7+ Years of Experience in API Manufacturing & CDMO
- Achieved ₹1.5 Crore Annual Operational Excellence Savings
- Delivered ₹20 Lakhs Annual Energy Savings
- Successfully Executed 12+ Technology Transfer Projects
- Supported 15+ Engineering & Commercial Batches
- Executed 20+ Process Validation Batches
- Improved Product Yield by 5+%
- Increased Solvent Recovery Efficiency by 12%
- Reduced Manufacturing Cycle Time by 8%
- Experience with 10 KL Reactors
- Managed Commercial Batch Sizes up to 1400 kg
- Experienced in GMP, cGMP, ICH Guidelines, Data Integrity, Change Control, RCA & CAPA
Core Competencies
- R&D to Commercial Manufacturing Transfer
- Process Scale-Up (Lab → Pilot → Plant)
- New Product Introduction (NPI)
- Process Validation & Engineering Batches
- Reaction Engineering & Reactor Operations
- Crystallization, Filtration & Drying.
- Process Chemistry & Reaction Kinetics
- Mass & Heat Transfer Optimization
- GMP Manufacturing Compliance
- Yield Improvement & Cycle Time Reduction
- Deviation, OOS/OOT Investigation Support
- Process Troubleshooting & RCA
- PFD & P&ID Development
- Equipment Selection & Process Desig
- Utilities Optimization
- Solvent Recovery & Cost Reduction
- Multi-Project Execution
- Stakeholder & Client Coordination
- Technical Reporting & Presentations
Languages
- Telugu, Native
- German, A1
- English, Advanced (Speaking, Reading, Writing)
- Hindi, Intermediate (Speaking, Reading), Basic (Writing)
Timeline
Senior Engineer
Matrix Pharma Corp.
06.2023 - Current
Associate
Eisai Pharmaceuticals India Pvt. Ltd.
10.2018 - 06.2023
Bachelor of Technology - Chemical Engineering
Jawaharlal Nehru Technological University
Diploma - Chemical Engineering
State Board of Technical Education & Training