Balaji P
Tuticorin
Summary
Results-driven Production Specialist with expertise in regulatory compliance and downstream processes. Successfully scaled up six molecules using ATF technology, and spearheaded MES MBR implementation, enhancing documentation efficiency. Proven track record in deviation investigation and corrective actions, achieving zero recurring issues while fostering collaboration across teams.
Overview
6
6
years of professional experience
Work History
Production Specialist
Dr. Reddy’s Laboratories
Hyderabad
08.2021 - Current
- Scaled up six molecules to 1 KL facility using ATF technology, ensuring compliance with global regulatory standards.
- Spearheaded implementation of MES MBR integrated with ABB middleware for three products, improving electronic documentation efficiency.
- Investigated over 190 deviations and executed more than 200 corrective and preventive actions, achieving zero recurring deviations.
- Qualified critical downstream processing consumables and equipment, including single-use assemblies and Freeze-Thaw systems.
- Coordinated technology transfer for downstream processes, collaborating effectively with QA and regulatory teams.
Junior Executive
Kemwell Biopharma
Bangalore
10.2020 - 08.2021
- Authored UNICORN recipes and provided AKTA troubleshooting, significantly enhancing operational reliability.
- Developed comprehensive Batch Records for validated large-scale downstream manufacturing processes.
- Authored detailed SOPs for newly qualified equipment, ensuring regulatory compliance and operational consistency.
Trainee
Biogenomics Ltd
Pondicherry
02.2019 - 09.2020
- Actively participated in downstream manufacturing processes for recombinant proteins.
- Gained hands-on experience with manual and automated UNICORN systems and PALL TFF systems.
- Authored and standardized SOPs for new equipment, streamlining operational practices.
Education
M. Tech - Biotechnology
Anna University
TamilNaduB. Tech - Biotechnology
Anna University
TamilNaduSkills
- Regulatory Compliance
- Downstream Technical expertise
- Investigation of Deviation and OOS
- Quality Management
- Qualification & Validation
- MES MBR designing
- UNICORN Method Writing
- ABB Recipe designing
- E-Val document preparation
- Chromatographic purification
- Tangential Flow Filtration
- Investigation of Deviations and OOS
- Equipment qualification
- CSV
- Preparation of GMP documents
- Risk assessments
Accomplishments
- Successfully scaled downstream processes for six molecules, facilitating timely market entry (domestic and international)
- Successfully implemented electronic logbooks (E-Logbooks) and MES MBRs, modernizing documentation practices at commercial manufacturing facilities
- Executed global PPQ campaigns in compliance with international regulatory frameworks
- Introduced and optimized membrane chromatography processes at a commercial 1 KL facility
- Pioneered the implementation of ABB middleware software, effectively addressing MES MBR challenges, and significantly reducing capital expenditures
- Authored standardized SOPs and protocols, improving operational consistency across multiple production sites
- Managed the qualification of downstream single-use equipment and consumables, strictly adhering to CSV standards
References
Available upon request.
Timeline
Production Specialist
Dr. Reddy’s Laboratories
08.2021 - Current
Junior Executive
Kemwell Biopharma
10.2020 - 08.2021
Trainee
Biogenomics Ltd
02.2019 - 09.2020
M. Tech - Biotechnology
Anna University
B. Tech - Biotechnology
Anna University