Biopharma R&D & Production Roles

Roles & Responsibilities
• Execute upstream and downstream process development including scale-up, tech transfer, and process characterization for biologics
• Perform purification of mAbs, glycoproteins, and ADCs using chromatography and filtration techniques
• Develop and validate analytical methods including HPLC/UPLC, ELISA, MS, and cIEF for product characterization and stability studies
• Handle single-use bioreactors, CO₂ shakers, and aseptic mammalian cell culture operations in GMP environment
• Manage production filling activities including depyrogenation, sterilization, lyophilization, vial filling, and sealing operations
• Supervise labelling and packing operations ensuring QMS compliance and track & trace documentation
• Ensure adherence to cGMP standards, manage deviations, CAPA, change control, and validation activities
• Support preventive maintenance, documentation, and continuous improvement initiatives

Qualification
•B.Pharm
• Any Graduate (for selected packing roles)

Experience
• 1–12 years depending on role and department
• 2–12 years for R&D (USP/DSP and AR&D)
• 2–10 years for Production – USP & DSP
• 1–9 years for Production – Filling
• 1–6 years for Labelling & Packing

Skills
• Upstream and downstream biologics processing expertise
• Chromatography and purification techniques
• Analytical method development and validation
• GMP, QMS, CAPA, and change control knowledge
• Aseptic processing and mammalian cell culture handling
• Production planning and equipment operation
• Strong documentation and regulatory compliance awareness

About the Company
Hetero Biopharma Ltd is a leading biologics and biosimilars company focused on research, development, and large-scale manufacturing of biopharmaceutical products. With advanced GMP-certified facilities and strong expertise in upstream and downstream processing, the company offers excellent career growth opportunities in R&D and production within a globally recognized biopharma environment.