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) .
- Robust 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 Product Characterization

Key Competencies

- Strong analytical and problem-solving skills
- Scientific rigor and attention to detail
- Effective communication and stakeholder collaboration
- Ability to manage multiple priorities and deliver results within timelines

Location: Hyderabad Experience: 2–8 Years

Education: Master's Degree in Life Sciences or related field

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