Founded in 2001, we are a clinical-stage biopharmaceutical company focused on delivering ground-breaking cancer therapeutics to patients globally.
Post : Research Associate
Qualification & Experience
• M.Pharm degree
• 6–8 years of relevant experience
Key Responsibilities
• Hands-on experience in developing and scaling novel oral and parenteral drug delivery systems to improve solubility, bioavailability and/or overall product performance.
• Expertise in lipid-based formulations, nanosuspensions/nanoparticulate systems, and biodegradable polymer-based delivery technologies.
• Experience in development, scale-up, technology transfer and GMP manufacturing of drug products for:
o Monoclonal antibodies (mAbs)
o Antibody-drug conjugates (ADCs)
o Injectable drug products
• Expertise in process validation and troubleshooting during GMP manufacturing operations.
• Strong understanding of physicochemical properties influencing molecule developability and clinical progression.
• Strong understanding of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), with ability to identify, evaluate and control parameters affecting product quality, process robustness and regulatory compliance during development and scale-up.
• Strong knowledge of cGMP requirements, with hands-on experience preparing, reviewing and maintaining GMP documentation, including : SOPs, Batch records, Protocols, Reports, Deviations, CAPAs, Change controls, Risk assessments
• Working knowledge of Quality by Design (QbD) principles, risk-assessment tools and process optimization.
• Experience supporting regulatory submissions such as ANDA, NDA and global filings.
Job Location : Bangalore
Share your resume at Email : tamil_s@aurigene.com
Last Date : 10th October 2026
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