N. PRAVIN KUMAR
Biotechnologist
Singapore
Summary
Biotechnologist with over 8 years of experience in sterile pharmaceutical manufacturing within multinational organizations, including Novartis and Biocon. Strong expertise in GMP-compliant operations, batch record review, equipment qualification, deviation investigations, and regulatory inspection readiness. Experienced in supporting FDA, EMA, NPRA, and other global regulatory audits in ISO-classified cleanroom environments.
Overview
9
9
years of professional experience
2
2
Certificates
Work History
Biotechnologist
Novartis (Singapore) Pte. Ltd.
07.2020 - Current
- Acted as Deputy Team Leader, ensuring effective daily task delegation to team members in alignment with approved production schedules.
- Reviewed and approved LOTO (Lockout/Tagout) permits to enable safe execution of maintenance, troubleshooting, and preventive maintenance activities by service teams.
- Provided asset care ownership and performed immediate first-line troubleshooting to minimize production downtime.
- Revised and updated Standard Operating Procedures (SOPs) and equipment logbooks to improve operational efficiency and ensure compliance with quality standards.
- Supported commissioning and qualification of six bioreactors, including P&ID walkdowns, slope verification, Material of Construction (MOC) verification, and EM color flow designation.
- Raised and managed Active Change Control (ACC) for process and production-related changes in accordance with quality systems.
- Contributed continuous improvement initiatives, including implementation of safety ladders to enhance operator safety during production activities.
- Executed sterile manufacturing operations using MES, Delta-V, and SAP, ensuring full compliance with GMP requirements.
- Performed batch manufacturing record review to ensure right-first-time documentation and timely batch disposition.
- Supported deviation, OOS, and OOE investigations, including root cause analysis and CAPA implementation.
- Maintained inspection readiness and actively supported global regulatory audits and internal quality inspections.
Manufacturing Support
Renergy Engineering LLP (Assigned to Novartis Singapore)
07.2019 - 07.2020
- Supported raw material dispensing activities for sterile drug manufacturing batches in accordance with GMP requirements.
- Performed Bowie-Dick tests and chamber vacuum leak tests for autoclave systems to ensure sterilization effectiveness.
- Executed pre- and post-batch sterile manufacturing activities, including operation of glassware washers and accessory cleaning systems.
- Conducted routine Water for Injection (WFI) sampling in compliance with quality and regulatory standards.
- Executed approved SOPs related to production operations, material handling, and cleanroom housekeeping.
- Ensured all activities conducted in classified cleanroom environments strictly complied with GLP, GMP, GDP, laboratory policies, and safety guidelines.
- Actively supported and participated in all regulatory audits and inspection readiness activities.
Biotechnology Associate
Biocon Sdn. Bhd.
06.2017 - 07.2019
- Executed equipment qualification and validation activities for sterile manufacturing systems in accordance with GMP requirements.
- Performed CIP and SIP validation, temperature mapping, and routine microbiological sampling to ensure process and environmental compliance.
- Authored, reviewed, and maintained SOPs, validation protocols, and technical documentation in line with quality standards.
- Supported and successfully passed regulatory inspections and audits conducted by FDA, EMA, NPRA, and ANVISA.
Education
Bachelor of Science - Biotechnology
AIMST University
Malaysia01.2011
High School Diploma -
Klang High School
Malaysia 04.2001 -
Skills
Sterile Manufacturing Operations, GMP, GLP, GDP, Batch Record Review, Deviation/OOS/OOE Investigation, Equipment Qualification (IQ/OQ/PQ), Environmental Monitoring, Cleanroom Operations (ISO 5–8), MES, Delta-V, SAP, CAPA, Regulatory Audit Support
SAP
Delta-V
Accomplishments
- Completed Respond to Fire and Hazardous Materials Emergency training, including CERT First Aider (BFA with CPR & AED) certification.
- Participated in Human Relations Skills and Emotional Intelligence (EQ) development programs.
Certification
CERT First Aider (BFA with CPR and AED)
Timeline
CERT First Aider (BFA with CPR and AED)
09-2024
Respond to Fire and Hazmat Emergency
04-2024
Biotechnologist
Novartis (Singapore) Pte. Ltd.
07.2020 - Current
Manufacturing Support
Renergy Engineering LLP (Assigned to Novartis Singapore)
07.2019 - 07.2020
Biotechnology Associate
Biocon Sdn. Bhd.
06.2017 - 07.2019
High School Diploma -
Klang High School
04.2001 -
Bachelor of Science - Biotechnology
AIMST University
PUBLICATION
Kumar, N. P., et al. (2012). Antimicrobial activity of different tissues of Channa striatus. Asian Pacific Journal of Tropical Disease, 2(Suppl), S302–S305.
References
Available upon request
PUBLICATION
Kumar, N. P., et al. (2012). Antimicrobial activity of different tissues of Channa striatus. Asian Pacific Journal of Tropical Disease, 2(Suppl), S302–S305.