Job
Description
Key Responsibilities : Leverage in-depth knowledge of ICH, USP, EP, and IP guidelines to write and review developmental protocols and analytical reports. Participate in the ADL team, contributing to new method developments, method qualifications, and process development quality analysis for recombinant proteins and biosimilars. Conduct LC-based method development for quality evaluations, including techniques like RP-HPLC, Ion Exchange (IEX), and glycan analysis. Lead CE-based method development for quality assessments of recombinant proteins. Perform analytical tasks to support different stages of process development, from clone selection to upstream and downstream process optimizations. Undertake method qualifications and transfers, ensuring seamless transitions to manufacturing, quality control, or external laboratories. Plan and execute stability studies for R&D batches, assess stability trends, and provide insightful conclusions based on data analysis. Plan and manage experiments and day-to-day activities in the laboratory. Coordinate with external laboratories for outsourced analytical activities and ensure proper communication. Maintain detailed equipment logs, documentation, and ensure compliance with good laboratory practices (GLP). Compile and review experimental data, ensuring high-quality documentation. Qualifications and Experience : Masters degree in Biotechnology, Biochemistry, or Pharmaceutical Sciences, with a focus on biotechnology or related fields. 7-9 years of hands-on experience in analytical development for recombinant proteins (including mAbs and biosimilars). Strong knowledge and understanding of proteins, with expertise in LC-based analysis and method development. Experience working with ICH, USP, EP, and IP guidelines and protocols. In-depth knowledge of good laboratory practices (GLP). Strong team player with excellent written and verbal communication skills. Required Skills : Expertise in protein sample preparation techniques (centrifugation, concentration, extraction, etc.). Proficiency in the operation and troubleshooting of LC and CE systems. Experience with common laboratory instruments (e.g., UV-Vis Spectrometer, weighing balances). Strong analytical thinking and data evaluation skills, with a solid understanding of statistical methods. Proficiency in using MS Office tools for documentation and data analysis. Commitment to maintaining data integrity and adhering to good documentation practices. Key Competencies : Strong attention to detail and quality-focused mindset. Ability to collaborate effectively within cross-functional teams. Excellent organizational and time-management skills. Ability to independently plan and manage multiple experiments and tasks.
