Scientist

As a candidate for this role, you will be responsible for the following key responsibilities: - Thorough knowledge of HPLC based analysis of recombinant proteins including RP-HPLC, SE-HPLC, and glycan analysis. - Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines. This includes writing and reviewing protocols, transfer plans, and reports. - Carry out day-to-day analytical work and collaborate with the Cell culture and downstream teams in Biotech R&D. - Set up product-related test/release specifications and analytical protocols for Biotech products. - Design in-house/outsource methods for Physico-chemical characterization of biological products. - Coordinate with QC for the smooth implementation of new methods. - Maintain equipment logs and documentation in the lab. - Monitor and maintain stability of various products in Biotech. - Prepare lab-related documents, regulatory submission documents, and provide QC support (SOP, STP, COA, MOA, Specification). - Interpret data and write reports in support of regulatory submissions. - Review analytical data for in-process & stability related activities. Qualifications required for this role: - Strong knowledge of HPLC based analysis of recombinant proteins. - Experience in method development, qualification, and transfer following ICH/USP/EP/IP guidelines. - Good understanding of analytical work in a Biotech R&D setting. - Ability to design analytical protocols for Biotech products. - Knowledge of Physico-chemical characterization of biological products. - Proficiency in interpreting data and writing reports for regulatory submissions.,