Sr. Scientist

Position Summary

We are seeking a highly motivated Scientist to join our Pharmaceutical Development team. This role will contribute to laboratory-based biologics drug product development by executing assigned studies and, as experience permits, planning and leading smaller defined work items under general to broad supervision. The role will support instrument setup and laboratory capability, phase-appropriate formulation and drug product process development, and physicochemical/bioanalytical characterization using state-of-the-art methods and equipment, including but not limited to UPLC or HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred), charge variant analysis, particle analysis, CE-SDS, and other physical-property characterization.

The successful candidate will collaborate with internal and external partners, communicate results and recommendations, and flexibly support multiple development projects in a fast-paced team environment. Experience with LC and iCiEF is required.

• Contribute to the setup, operation, maintenance, and routine troubleshooting of laboratory instruments; support method development and draft related procedures, reports, SOPs, and best-practice documentation.
• Independently execute assigned experiments and may plan or lead smaller, well-defined studies or work items supporting phase-appropriate formulation and drug product process development.
• Analyze and interpret experimental data, identify trends or atypical results, draw scientifically supported conclusions, and recommend next steps within defined project parameters; elevate complex issues as appropriate.
• Draft study plans, development reports, technical memos, and other scientific documentation with review from more experienced colleagues or management as appropriate.
• Collaborate with project management, quality assurance, analytical, R&D, non-clinical, manufacturing, and external partners to support development activities, technology transfer, and clinical material production.
• Communicate study progress, timelines, results, risks, and recommendations clearly to the manager and project team to support alignment and timely decision-making.
• Perform physicochemical and bioanalytical characterization using established analytical instrumentation and techniques and contribute to optimization of methods when needed.
• Prepare samples, solvents, standards, buffers, and other solutions with accurate calculations, weighing, documentation, and adherence to laboratory safety and Good Documentation Practices.
• Maintain laboratory notebooks, study documentation, inventory, and instrument maintenance schedules; contribute to laboratory organization and process improvements and may provide guidance to less-experienced colleagues on established procedures.
• Perform other duties as assigned.

• Working to strong understanding of the biochemical and physical properties of therapeutic biologics, including proteins and other relevant modalities, and of commonly used protein quantification and characterization approaches.
• Relevant experience with formulation, drug product, analytical, or related development activities for biologics; able to apply established scientific principles and procedures to assigned work.
• Hands-on experience with commonly used characterization and analytical instruments in a biologics drug product laboratory, with sufficient understanding of assay principles to independently perform routine work and troubleshoot minor instrument or method issues.
• Ability to analyze testing results, recognize trends and out-of-trend or atypical data, summarize findings, and make scientifically supported conclusions and recommendations within defined parameters.
• Strong technical writing skills with the…