Scientist – Bioanalytical R&D;
Qualification:
Master’s degree in Life Sciences, Biotechnology, Biochemistry, Immunology, Pharmaceutical Sciences, or related disciplines with 2–8 years of relevant industry experience.
Role Overview
We are looking for a highly motivated Bioanalytical Scientist with hands-on experience in ELISA and Product-Related Impurity (PRI) assays, including Host Cell Protein (HCP), Host Cell DNA (HCD), and Protein A Leachate (PAL) testing. Exposure to flow cytometry, cell culture, and cell-based bioassays will be an added advantage. The candidate will support biologics/biosimilar development programs through method development, qualification, characterization, and routine analytical testing.
Key Responsibilities
Develop, optimize, qualify, and execute bioanalytical methods to support project requirements.
Perform ELISA-based assays, including HCP, HCD, PAL, and other impurity or characterization assays.
Conduct product characterization studies and support method transfer/co-qualification activities.
Perform data analysis, interpretation, troubleshooting,



and technical reporting.
Support cell culture, flow cytometry, and cell-based bioassays, as applicable.
Maintain accurate documentation and ensure compliance with GDP, quality systems, and laboratory safety standards.
Support equipment qualification, calibration, and laboratory operational activities.
Prepare project updates, technical reports, and presentations; collaborate effectively with cross-functional teams.
Follow SOPs and undertake additional responsibilities assigned by the Team Lead or Function Head.
Required Skills
Hands-on experience with ELISA and PRI methods (HCP, HCD, PAL).
Solid understanding of bioanalytical method development, qualification, and troubleshooting.
Experience in data analysis, technical documentation, and quality-compliant laboratory practices.
Preferred Skills
Flow Cytometry
Mammalian Cell Culture
Cell-Based Potency/Functional Bioassays
Biologics/Biosimilar Produ

📌 Scientist - Bioanalytical R&D (Hyderabad)
🏢 Aurigene Pharmaceutical Services
📍 Hyderabad