Suraj Kumar

About Suraj Kumar

Biotech professional with 6+ years of comprehensive experience in the biosimilar…

Experience

1. Senior Executive- Bioassay

   INVITRON ADVANCED ANALYTICS

   Oct 2024 — Present · Hyderabad, IN

   Hands-on experience in performing Cell-based bioassays of insulin analogues proteins & Peptides (R&D, QC, DS, DP & Stability samples of Semaglutide, Liraglutide & Tirzepatide along with planning, imparting training & execution.• Execution of Method development, Method validation, Method verification / Feasibility run of Proteins & Peptides as per Q2(R2) guidelines.• Subculturing, revival, banking, cryopreservation & maintenance of adherent & suspension cell lines like CHO-K1 GLP1R, UMR-106 & WIL2-S.• Preparation, review & approve Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), Specifications, Method validation protocol & report, Certificate of Analysis (COA) & other cGMP/GDP documents to ensure compliance with corporate & regulatory standards.• Proficient in reviewing technical documents, change controls, deviations & GMP-related documents.• Internal committee member for Institutional Biosafety Committee (IBSC) for IBSC certification provided by DBT, Govt. of India.• Responsible to investigate the root cause for Lab related QMS elements & implementation of CAPA.• Responsible for managing records, ensuring timely completion & documentation closeout activities with the necessary supporting evidence.• Tracking & Qualification of Analytical instruments & Equipment’s (IQ/OQ/PQ), Calibration & Verification.• Ensuring alignment of SOPs & documentation with procedures, ICH, cGMP, GDP & other applicable pharmaceutical guidelines & regulations.• Contributing to operational, quality improvement & upgradation initiatives, programs & projects.• Strong ability to communicate effectively at all organizational levels, with excellent written & verbal communication skills.• Proficient in MS Office tools such as Excel, Word & PowerPoint. Capable of multitasking & prioritizing tasks efficiently.• Tracking & Inventory management for the consumables & reagents; stock pertaining & ordering the same from time to time.

Skills

• Research
• Microsoft Excel
• Management
• Pharmaceutical Industry