Senior Scientist, Analytical R&D

<p><b><span style="font-size:inherit">Senior Scientist –Analytical Similarity &amp; Comparability (Biosimilars)</span></b><span style="font-size:inherit"> </span></p><p><b><span style="font-size:inherit">Position Summary</span></b><span style="font-size:inherit"> </span><br /><span style="font-size:inherit">The Senior Scientist is responsible for CQA assessments, defining analytical strategies, interpreting data, writing protocols and preparing scientific reports to support Forced Degradation, Analytical Similarity, and Comparability studies for biosimilar programs. </span></p><p><b><span style="font-size:inherit">Key Responsibilities</span></b><span style="font-size:inherit"> </span></p><ul><li><p><span style="font-size:inherit">CQA assessment for biosimilar programs. </span></p></li><li><p><span style="font-size:inherit">Author or review the study protocols with clear scientific rationale, acceptance criteria, and CQAbased strategy. </span></p></li><li><p><span style="font-size:inherit">Interpret analytical data and provide concise, scientifically sound summaries. </span></p></li><li><p><span style="font-size:inherit">Author or review study reports and contribute technical content to regulatory submissions. </span></p></li><li><p><span style="font-size:inherit">Review analytical results for accuracy and alignment with study objectives. </span></p></li><li><p><span style="font-size:inherit">Collaborate closely with analytical development, process development, and regulatory teams. </span></p></li></ul><p><b><span style="font-size:inherit">Qualifications</span></b><span style="font-size:inherit"> </span></p><ul><li><p><span style="font-size:inherit">MS (8–10&#43; yrs) or PhD (4–6&#43; yrs) in Biochemistry, Analytical Chemistry, Biotechnology, or related field. </span></p></li><li><p><span style="font-size:inherit">Experience with biosimilar analytical characterization and scientific report writing. </span></p></li><li><p><span style="font-size:inherit">Strong understanding of forced degradation, analytical similarity, and ICH comparability principles. </span></p></li><li><p><span style="font-size:inherit">Excellent scientific writing, data review, and communication skills. </span></p></li></ul><p><b><span style="font-size:inherit">Preferred Technical Skills</span></b><span style="font-size:inherit"> </span></p><ul><li><p><span style="font-size:inherit">Handson or oversight experience with key characterization methods (e.g., HPLC/UPLC based Analytical chromatography techniques, CESDS, cIEF, LCMS, glycan analysis, AUC, DLS, FTIR, DSC, CD). </span></p></li><li><p><span style="font-size:inherit">Familiarity with degradation pathway analysis (oxidation, deamidation, aggregation, fragmentation). </span></p></li><li><p><span style="font-size:inherit">Working knowledge of CQA assessment, risk ranking, and biosimilarity principles. </span></p></li><li><p><span style="font-size:inherit">Ability to interpret complex multiattribute datasets and provide clear scientific justification. </span></p></li><li><p><span style="font-size:inherit">Experience preparing AS reports, comparability assessments, and regulatoryready documentation. </span></p></li></ul>