Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic
PRADEEP KUMAR MALAPATI

PRADEEP KUMAR MALAPATI

Bengaluru

Summary

Experienced Technology Transfer and Process Development professional with 20 years of expertise in managing all phases of product development, scale-up, and commercialization. Adept at providing end-to-end support for new projects, from CAPEX estimation to execution. Skilled in contract manufacturing, meeting customer requirements, and handling complex products such as New Chemical Entities (NCEs), synthetic APIs, and high-potent molecules. Proven abilities to optimize fermentation downstream processing strategies, including microfiltration (MF), nanofiltration (NF), chromatography, crystallization, and lyophilization. Expertise in process validation, regulatory compliance, and hands-on execution of manufacturing processes. Proficient in troubleshooting, deviation management, and ensuring adherence to cGMP guidelines, ensuring seamless transition from R&D to commercial production.

Overview

21
21
years of professional experience

Work History

Associate Manager, TT-MSAT

BIOCON LIMITED
02.2014 - Current
  • Spearhead technology transfer initiatives, ensuring efficient transition of processes from R&D to large-scale commercial production
  • Provide comprehensive support across CAPEX estimation, project scale-up, and execution, ensuring optimal resource allocation and timely project delivery
  • Design and optimize purification workflows, utilizing advanced chromatography, membrane filtration (MF/NF), crystallization, and lyophilization techniques to ensure product purity
  • Prepare detailed technical documentation including Process Flow Diagrams (PFD), Piping and Instrumentation Diagrams (P&ID), Batch Production Records (BPR), and validation reports to support process compliance and regulatory submissions
  • Ensure adherence to cGMP, regulatory, and safety guidelines throughout the entire project lifecycle, from development through to commercialization

Senior Executive, Process Engineer (Custom Pharma Division)

DR. REDDY'S LABORATORIES
04.2008 - 01.2014
  • Led contract manufacturing operations, focusing on fulfilling customer requirements for complex products such as New Chemical Entities (NCEs), synthetic APIs, and high-potent molecules
  • Managed the preparation of technology transfer and validation documentation, including PFD, P&ID, BPR, Safety, Health, and Environmental (SHE) package, and Process Equipment (PE) packages
  • Oversaw the selection of appropriate manufacturing equipment, process scale-up planning, and coordinated plant operations to ensure seamless execution on the shop floor
  • Executed and monitored process optimization strategies for scale-up, ensuring quality, efficiency, and compliance with cGMP standards
  • Compiled and reviewed campaign reports post-execution, ensuring all documentation is complete and in compliance with regulatory standards

Executive, Production Department

INOGENT LABORATORIES (A GVK BIO GROUP)
08.2006 - 04.2008
  • Managed shift operations in synthetic API production, ensuring adherence to batch production schedules and quality standards
  • Operated and supervised batch reactors, Nutsche filters, Sparkler filters, and drying equipment (tray/vacuum dryers) to ensure production efficiency and product consistency
  • Implemented and enforced SH&E protocols to maintain safe, compliant, and efficient operations across production processes
  • Coordinated the execution of BPRs and SOPs, ensured critical process parameters were met, and maintained compliance with regulatory standards
  • Trained and mentored junior staff on production processes and safety procedures, enhancing team capability and performance

Junior Technical Officer, Production Department

DR. REDDY'S LABORATORIES
09.2004 - 07.2006
  • Gained comprehensive expertise in synthetic API production processes, focusing on reactor operations, filtration systems, and drying techniques
  • Independently managed shift operations, maintaining equipment functionality, and ensuring smooth production flow
  • Monitored and controlled critical process parameters, ensuring compliance with regulatory standards, cGMP, and SH&E guidelines
  • Facilitated cleaning validation and preventive maintenance for equipment, ensuring uninterrupted production cycles and compliance with quality standards
  • Supported troubleshooting and process improvements in collaboration with QA and Engineering teams to drive operational excellence

Education

Master's Degree - Business Management

IGNOU
12.2025

Bachelor's Degree - Chemical Engineering

Mansarovar Global University
Madhya Pradesh
12.2023

Diploma - Chemical Engineering

Govt institute of chemical engineering
Visakhapatnam
12.2003

Skills

  • Technology Transfer & Process Scale-up
  • Fermentation Downstream Processing
  • Chromatography & Membrane Filtration
  • Crystallization & Lyophilization
  • Process Optimization & Troubleshooting
  • Regulatory Compliance & GMP Documentation
  • CAPEX Estimation & Plant Execution
  • Contract Manufacturing & Customer Requirement Management

Languages

English (Fluent)
Hindi (Fluent)
Telugu (Fluent)

Timeline

Associate Manager, TT-MSAT

BIOCON LIMITED
02.2014 - Current

Senior Executive, Process Engineer (Custom Pharma Division)

DR. REDDY'S LABORATORIES
04.2008 - 01.2014

Executive, Production Department

INOGENT LABORATORIES (A GVK BIO GROUP)
08.2006 - 04.2008

Junior Technical Officer, Production Department

DR. REDDY'S LABORATORIES
09.2004 - 07.2006

Master's Degree - Business Management

IGNOU

Bachelor's Degree - Chemical Engineering

Mansarovar Global University

Diploma - Chemical Engineering

Govt institute of chemical engineering

Similar Profiles

CREATE PROFILE
PRADEEP KUMAR MALAPATI