Logesh Kumar G

Bioprocess Engineer with 5+ years of experience in cGMP upstream manufacturing, MSAT, and biopharmaceutical process development. Demonstrated expertise in mAb cell culture (CHO), technology transfer, deviation investigation, CAPA management, and continued process verification — directly aligned with commercialization of biologic drug substances. Currently leading intensified upstream platform development in a CMC biologics role, building scalable, data-driven process frameworks.

Proven collaborator across R&D, CMC, QA, QC, and manufacturing functions, with a strong record of driving process consistency and cGMP compliance.

Lead Scientist – CMC Biologics, Biopharmaceutical Process Development at Syngene International Limited (2025-10 – Present)

• Leading upstream process development for CMC biologics programs, evaluating and optimizing fed-batch and perfusion-based platforms to establish scalable, phase-appropriate manufacturing processes.
• Engineering pseudo-perfusion models using optimized media and feed combinations to evaluate dual-platform compatibility between N-1 perfusion and high seed density (HSD) fed-batch processes.
• Building data-driven process development frameworks to support technology transfer to GMP manufacturing and CMC regulatory submissions.
• Collaborating cross-functionally with analytical development, downstream processing, manufacturing, and regulatory teams to meet project timelines and quality standards.

Senior Executive – Bio Bulk Manufacturing (Upstream MSAT) at Enzene Bioscience Ltd (2021-08 – 2025-09)

• Served as functional lead for client biologics programs, managing end-to-end technology transfer from development into cGMP manufacturing, including process scale-up from bench to 2000 L single-use bioreactors (BIOSTAT Sartorius) and SS-ATF systems.
• Executed process transfer activities including authoring and reviewing scale-up reports, MFRs, BMRs, SOPs, validation protocols, and risk/impact assessments in compliance with cGMP requirements.
• Led deviation investigations and root cause analyses (RCA); implemented CAPAs that reduced harvest cycle time by 50% at 2000 L scale through systematic process redesign.
• Resolved dissolved oxygen deviation at N-2 stage and 2000 L fed-batch scale using PID controller tuning and gas flow rate optimization.
• Maintained batch-to-batch process consistency through trend monitoring and IPQC analysis; contributed to preparation of Continued Process Verification (CPV).
• Led and executed cleaning validation campaign for EMA submission; achieved zero observations during QP audit — demonstrating strong command of regulatory documentation and change control processes.
• Collaborated with Global CMC, QA, QC, MSAT, and EM teams during client audits and regulatory inspections; served as process SME for GMP facility.
• Streamlined ATF system utilization resulting in 10% reduction in production cost and 20% improvement in continuous operation uptime through systematic process evaluation.
• Manufactured multiple mAb drug substances in CHO cell culture: Adalimumab, Bevacizumab, Cetuximab, Denosumab, Pertuzumab, Infliximab, and Anti-IL38 antibody.
• Commissioned and qualified part washer and ATF filtration systems; authored change controls, impact assessments, and qualification documentation.
• Designed Excel-based single-use P&IDs, filtration assemblies, and sterile connection schematics to support manufacturing and tech transfer documentation.

Project Associate – Bioprocess & Nutraceuticals at Department of Biotechnology / Theevanam Additives & Nutraceuts Pvt Ltd – IIT Madras Bio-Incubator (2019-02 – 2019-07)

• Led pilot-scale processing of nutraceutical compounds (beta-glucan) and supported formulation development to extend product shelf-life.
• Conducted on-farm trials and real-time data acquisition from aquaculture facilities.

Intern – Downstream Biologics (PAS) at Biocon Research Limited (2018-06 – 2018-12)

• Executed chromatography studies on ÄKTA Explorer and ÄKTA Pure systems including buffer preparation, column packing, and qualification; supported process characterization studies for downstream biologics.

M.Tech in Bioprocess Technology – Institute of Chemical Technology (ICT), Mumbai

B.Tech in Biotechnology – MEPCO Schlenk Engineering College, Sivakasi, Tamil Nadu