Immunogenicity & Large Molecule Bioanalysis

Job Description

We are hiring! Function: Immunogenicity & Large Molecule Bioanalysis Department: Biotechnology R&D Qualification M.Sc./M.Tech– Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline with 7–10 years of relevant industry experience, OR Ph.D. in Immunology, Pharmaceutical Biotechnology, or a related discipline with 1–3 years of relevant industry experience. Position Title: Manager-2 Job Location: Vadodara, Gujarat Job Description: 1. To support the discovery, preclinical, and clinical development of biologics, including monoclonal antibodies, recombinant proteins, peptides, and other biotherapeutics. 2. Hands on experience on method development, critical reagent generation, bioanalytical method validation, and study sample analysis for pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity (ADA/NAb), and biomarker assessments. 3. Rhe role requires strong technical expertise in immunology, regulated bioanalysis, immunoassay optimization, data analysis, troubleshooting, and hands-on laboratory execution. Hands-on experience with ELISA, cell-based assays, MSD, flow cytometry etc. 4. Ensure compliance with regulatory guidelines, including FDA, EMA, ICH, and GLP/GCLP requirements. Ensure data integrity and adherence to quality standards. 5 Serve as a technical lead for assigned projects. Coordinate with other departments to facilitate project execution. 6.Draft and review study protocols, method development reports, validation reports, technical summaries, and regulatory documents. Please share your resume at : Rosemary.varghese@sunpharma.com Dr Nitin Nage Ph.D. Arnab Sinha Roy