Sivakumar Thiyagarajan
Downstream Process Development Scientist
- Role
- Principal Investigator at Syngene International Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sivakumar Thiyagarajan
Well experienced in Process development of novel bispecific monoclonal antibody, process scale–up, and tech transfer to 2 KL large scale GMP Manufacturing. Have deep understanding of 2 KL large scale GMP manufacturing, and served as single point of contact for manufacturing support, exchanging key information, monitoring batch trends, investigating deviations and suggesting CAPAs.Have experience in leading DSP Team and skillful in experimental designing, planning, supervising and directing studies and present key objectives in CMC Meeting.Have strong leadership skills and could collaborate with cross functional teams.Authored and reviewed regulatory document, providing technical inputs. Experienced in performing high quality statistical analysis, preparing reports and presentations and served as Subject matter expert (SME) in providing technical inputs.Efficient in Capex planning, budget planning, team resource planning, recruiting new employees for the team, arranging seminars to further the knowledge capital of the team.Effectively collaborated with CDMOs and CROs for outsourcing of projects. Experienced in screening resin for affinity chromatography, intermediate & polishing steps and well versed in scouting studies and key parameter optimization. Proficient in handing and troubleshooting purification skids and skillful in packing lab & large scale chromatography columns.
Experience
Principal Investigator
Jun 2024 — Present · Bengaluru, IN
Supporting the group with both early stage and late stage Downstream process development of Fusion bispecific monoclonal antibodies in support of CMC objective. • Currently leading technical team focused on process development, scale-up, technology transfer and GMP scale process monitoring.• Enabled the group with finalizing process lock, consistency run, Scale-up and tech transfer of Novel bispecific mAb molecule till commercial GMP manufacturing scale.
Education
The Hong Kong University of Science and Technology
Doctor of Philosophy (PhD), Life Science
2014 — 2018
Bharathidasan University
B.TECH, BIOTECHNOLOGY
2003 — 2007
AKT ACADEMY
12TH grade/ High school degree
2001 — 2003
Vellore Institute of Technology
M.TECH, BIOTECH
2007 — 2009
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