Analytical Development Scientist (Non PhD)

Roles & Responsibilities:

• Execution of experiments for analytical method development/ qualification/ transfer, in-process/ stability sample testing, biosimilarity analysis and for evaluation of new high throughput formats of testing using chromatography (HPLC/UPLC), electrophoresis /capillary electrophoresis, UV spectrophotometer, Solo-VPE and other high-end analytical tools. Sample analysis in GC, Atomic absorption spectroscopy (AAS), Charged Aerosol Detector (CAD) etc. Glycan analysis.
• Sequential and logical planning of experiments.
• Record the experiment details (procedure, controls, analyses, and observation of the experiments) accurately and completely following good documentation practices in electronic laboratory notebook.
• Compilation, and interpretation of experimental data
• Communication of data to cross-functional teams, compilation of data for reports and participate in internal group meetings.
• Prepare documents such as method development reports, protocols, instrument operation procedures, author change controls and deviations.
• Perform literature survey of assays, support in experimental design based on historical data and troubleshooting of experiments
• Maintain equipment and instruments in coordination with instrumentation team and support installation of new equipment and prepare Equipment/Instrument operating procedures
• Regularly track inventory of consumables/ critical reagents and making sure they are ordered and follow-up of the ordered material and support in laboratory maintenance.
• Participate in QMS related activities.

Education:

• Degree in life sciences such as biology, biochemistry, biotechnology, analytical chemistry or closely related field
• M.Pharma/M.Sc/M.Tech with 3-8 years of research experience

Required Experience:

• Experience in leading biopharmaceutical organizations, 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. Glycan analysis. Additional experience in excipient analysis using ELSD, CAD, and MS platforms is highly valued.
• 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 etc. Higher order structure analysis techniques (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, with 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. Proficiency in electronic laboratory notebook (eLN) systems is also preferred.
• Effective communicator and team player, capable of articulating scientific concepts, challenges, and solutions clearly.
• Familiarity with Empower Method Validation Manager is an added advantage