Prem Kumar M
Bengaluru
Summary
Dynamic professional with extensive experience at Biocon Limited, excelling in process optimization and quality management. Proven decision-making and problem-solving skills, successfully scaling projects from R&D to plant level. Adept at collaboration and multitasking, ensuring timely deliveries while enhancing operational efficiency through effective documentation and training initiatives.
Overview
3
3
Languages
18
18
years of professional experience
Work History
Assistant Manager
Biocon Limited
Bengaluru
02.2016 - Current
- Executed process development and initiation activities for bulk products, facilitating capacity enhancement and recovery improvement.
- Troubleshot process issues and established robust processes through successful trial batches, enhancing product reliability and consistency at plant scale.
- Monitored R&D experiments and recommended modifications to support process development and optimization.
- Scaled existing products from laboratory to plant scale via demonstrations, trial batches, development, and validation activities to ensure successful transition.
- Prepared subsequent manufacturing versions based on trial-batch observations and reviewed project documentation including MFRs, e-BMRs, and risk assessments.
- Prepared and reviewed process documentation including PFDs, P&IDs, equipment specifications, HAZOP studies, risk assessments, mass balances, and equipment suitability assessments.
- Ensured adherence to Standard Operating Procedures, product specifications, and Good Manufacturing Practices.
- Applied modern technologies and process improvements to increase workflow efficiency and overall process performance.
- Identified opportunities for plant and machinery modifications or improvements and provided resources for process-related implementation.
- Supported Track wise CAPA projects,and followed good laboratory practices.
- Developed standard operating procedures through document management system for improved operational efficiency.
- Coordinated with other departments to ensure smooth flow of operations.
Officer
Natco Organics Limited
Chennai
03.2014 - 01.2016
- Scaled projects from R&D to kilo-lab scale, enhancing transition efficiency.
- Executed SAP-related activities to streamline data management and process workflows.
- Documented observations systematically to support timely project delivery.
- Coordinated with other departments such as Quality Assurance, Procurement. for smooth functioning of operations.
Officer
Orchid Chemicals and Pharmaceuticals
Chennai
09.2008 - 03.2014
- Trained new employees on operational procedures and safety guidelines to ensure effective onboarding.
- Collaborated with team members to identify and resolve process bottlenecks for improved workflow.
- Developed standard operating procedures to streamline operations and clarify team roles.
- Monitored production performance and ensured quality standards were met.
Education
Bachelor of Science -
Pachaiyappa's College
Chennai04-2008
Skills
- Work planning
- Problem-solving
- Decision-making
- Team collaboration
- Multitasking
- Adaptability
Languages
English
Proficient (C2)
C2
Tamil
Advanced (C1)
C1
Hindi
Intermediate (B1)
B1
Timeline
Assistant Manager
Biocon Limited
02.2016 - Current
Officer
Natco Organics Limited
03.2014 - 01.2016
Officer
Orchid Chemicals and Pharmaceuticals
09.2008 - 03.2014
Bachelor of Science -
Pachaiyappa's College