E.Arun Kumar Email & Phone Number

• DBT-BITP Merit Holder in National Biopharmaceutical Occupational Standard & Competencies.(All India Ranking- 3rd) • Upstream-trained specialist in Recombinant Therapeutic Biosimilars at Sun Pharmaceutical R&D.• Grade-A LSSSDC Certified Biopharmaceutical Manufacturing Biologist. (Level-5/NSQF)• Specialized in Upstream Industrial Processing Equipments. • Well-versed in cGMP & SOP Documentation. (ICH-Q7 Guidelines)• Strategic Solution based In-Process Troubleshooter.• Successfully led multiple upstream bioprocess scale-ups, ensuring seamless transitions from small-scale development to large-scale commercial manufacturing with a focus on efficiency and compliance.• Proficiently managed equipment procurement, creating detailed User Requirement Specifications (URS), and overseeing the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes.• Headed the requalification of existing equipment, aligning with regulatory standards to minimize downtime and ensure uninterrupted production.• Prepared comprehensive Standard Operating Procedures (SOPs) for new equipment, meticulously overseeing their implementation.• Executed engineering batches to validate process scalability, optimizing manufacturing parameters for enhanced efficiency and yield.• Expertly managed the preparation of Master Cell Banks (MCB) and Working Cell Banks (WCB), prioritizing cell line integrity and quality.• Spearheaded process optimization initiatives, achieving consistency in the overall manufacturing process.• Prepared Batch Manufacturing Records (BMRs) and SOPs, ensuring product consistency and adherence to stringent quality standards.• Orchestrated process validation and cleaning validation activities, adeptly managing product changeovers to minimize downtime and resource waste.• Identified two novel human gut bacterial strains, with 16S rRNA sequence submitted in GenBank (NCBI-US)• Quality Control (Microbiology) - Adroit Analyst.• Certified by Knight Lab (USA) for project work on Gut Microbiome & Probiotics. (2019)