• Minimum of 5 years with Ph.D. or 12 years with M.S. of relevant experience in the biotechnology or pharmaceutical industry
• Experience in developing reagents and assays to quantitate host cell proteins (HCP).
• Experience with a variety of immunoassays and/or electrophoresis methods (such as ELISA, Biacore, Luminex, Capillary Electrophoresis, 1-D and 2-D gels and Blots, etc.)
• Experiences in assay development, qualification and tech transfer
• Exemplary leadership, communication, and problem solving skills
• Experience working in matrix environment with a good understanding of the cross-functional facets of development
• Background in proteomics, with experience running 2D DIGE and 2D Western Blotting
Within the Analytical Development organization, the Expert Scientist of Immunoassays & Electrophoresis will design and develop bioanalytical methods, support product and process development, develop and transfer release and stability assays for GMP testing for Phase 1 and Phase 2, according to Quality by Design principles in partnership with other Technical R&D functions, Quality and Regulatory.
• Develop Immunoassays & Electrophoresis methods according to Analytical Target Profiles
• Develop immunoassays for GMP release testing and transfer methods to GMP testing laboratories with compliance
• Provide analytical testing support for process development and serve as immunoassay and/or electrophoresis SME to project teams. Support process understanding
• Lead the characterization of clinical and commercial products using state-of-the-art immunological and electrophoresis technologies for analytics and data interpretation
• Serve as a SME and technical lead for Immunoassays or Electrophoresis-based assays. Proactively identify potential issues. Develop creative solutions to technical problems to meet project deliverables and milestones
• Write and review SOPs for analytical testing methods and development/qualification reports
• Present new findings at internal and external meetings. Collaborate with scientists from other functions.