Rajesh Kumar Chopra

About Rajesh Kumar Chopra

PROFESSIONAL EXPERIENCE Accomplished Biotech leader with 24+ years of expertise spanning Biotech R&D, Vaccine Manufacturing, Human Bood Plasma Fractionation and Sterile Injectable (liquid & lyophilized) production. Renowned for spearheading complex projects, including greenfield facility setups and brownfield renovations, while driving operational excellence. Adept at navigating regulatory landscapes, managing audits, and ensuring compliance with global standards (USFDA, WHO-Geneva, MHRA, EMA, TGA, ANVISA, ISO).President – Plant Operations (Jan 2025 – till date) ICHOR Biological Pvt. Ltd. Hyderabad, Telangana, India President operations for Drug substance & Drug Product Plant: Plasma Fractionation and purification of Human Albumin, IVIG, Factor-IX, Fibrinogen, Thrombin Drug Substances facility and Drug Product Plant –Hyderabad, Telangana. Establishing high compliance culture for manufacturing and testing of highest quality plasma derived products. Establishing road map for green filed project for EU-GMP standard high-capacity plasma fractionation facility. Purification Process improvements for Human Albumin, IVIG, Factor-IX, Fibrinogen, Thrombin to IP, EP and USP standards. Directed budget planning, cost control, and resource optimization initiatives to maximize ROI. Vice President – Manufacturing Excellence (till Dec,2024) Panacea Biotec Ltd. Punjab & Himachal Pradesh, India Directed operations for three facilities: Vaccine Drug Product (Formulation and Filling) facility – Baddi, Himachal Pradesh. Vaccine Drug Substance (8 production lines) – Lalru, Punjab. Oncology Sterile Injectable Plant – Baddi, Himachal Pradesh. Spearheaded global regulatory readiness for WHO, FDA, and EMA inspections, ensuring smooth compliance with international standards. Established strategic plans for capacity expansion and product portfolio diversification, aligning manufacturing processes with long-term organizational goals. Oversaw the commercial production of high-profile vaccine batches, including India\'s first Hexavalent Vaccine and bivalent Polio Vaccine. Directed planning, cost control, and resource optimization initiatives to maximize ROI. Achieved a 20% reduction in production cycle times for Hexavalent and Tetravalent vaccines by optimizing technology transfer and scale-up processes. Oversaw the preparation and submission of product dossiers for WHO approvals, achieving prequalification for multiple vaccine combinations.

Experience

1. President

   Ichor Biologics Pvt. Ltd

   Jan 2025 — Present · Hyderabad, IN

   President – Operations, Site Head-Manufacturing Excellence|Specialist in Vaccine & Human Blood Plasma Drug Substance, Drug Product, & Oncology Sterile Injectables

Education

• Kurukshetra University

  M.Sc, Biotechnology

  2000 — 2003

Skills

• Vaccines
• Biotechnology
• Technology Transfer
• Gmp
• Validation
• Glp
• Purification
• Capa
• Biopharmaceuticals
• Sop