Analytical Development Scientist

As a Scientist in this role, your primary responsibilities will include: - Executing experiments for analytical method development, qualification, and transfer - Conducting in-process and stability sample testing, biosimilarity analysis, and new high throughput formats of testing using chromatography (HPLC/UPLC), electrophoresis/capillary electrophoresis, UV spectrophotometer, Solo-VPE, and other high-end analytical tools - Analyzing samples in GC, Atomic absorption spectroscopy (AAS), Charged Aerosol Detector (CAD), and glycan analysis - Planning experiments sequentially and logically - Accurately recording experiment details in electronic laboratory notebook following good documentation practices - Compiling and interpreting experimental data - Communicating data to cross-functional teams, compiling data for reports, and participating in internal group meetings - Preparing documents such as method development reports, protocols, instrument operation procedures, change controls, and deviations - Performing literature surveys of assays, supporting experimental design based on historical data, and troubleshooting experiments - Maintaining equipment and instruments in coordination with the instrumentation team, supporting the installation of new equipment, and preparing Equipment/Instrument operating procedures - Regularly tracking inventory of consumables/critical reagents, ensuring orders are placed and following up on ordered material, and supporting laboratory maintenance - Participating in Quality Management System (QMS) related activities Qualifications required for this role are: - Degree in life sciences such as biology, biochemistry, biotechnology, analytical chemistry, or a closely related field - M.Pharma/M.Sc/M.Tech with 3-8 years of research experience Your experience should include: - Working in leading biopharmaceutical organizations and contributing to high-impact research and development initiatives - Strong expertise in chromatographic techniques including Ion Exchange (IEC), Reverse Phase (RP), Size Exclusion (SEC), and Hydrophilic Interaction Chromatography (HILIC) for protein therapeutics, as well as glycan analysis - Hands-on experience with a wide range of analytical instruments such as HPLC, UPLC, Capillary Electrophoresis (CE), UV-Vis Spectrophotometer, SoloVPE, Octet, Maurice, GC, and AAS, among others - Proficiency in higher order structure analysis techniques like CD spectroscopy, DSC, DLS, SEC-MALS, FTIR - Demonstrated ability to contribute to experimental design and troubleshooting within collaborative, cross-functional team environments - Skilled in data analysis using instrument-specific software and working knowledge of statistical tools for method evaluation and interpretation - Thorough understanding of regulatory guidelines including ICH, WHO, and USP for method development, qualification, transfer, and validation, with proficiency in electronic laboratory notebook (eLN) systems preferred - Effective communication skills and the ability to work well in a team, articulating scientific concepts, challenges, and solutions clearly - Familiarity with Empower Method Validation Manager is an added advantage,