Role Summary
Analytical Chemistry Advisor/Senior Advisor, Cell & Gene Therapy Products - Bioproduct Research and Development. The BR&D organization delivers medicines including cell and gene therapy products. You will be part of a diverse team delivering product and process understanding across a broad range of platforms, contributing to analytical methods and control strategies in a dynamic environment.
Responsibilities
- Enable the design, development, and implementation of analytical methodologies for the characterization and analysis of cell and gene therapy products.
- Contribute to the establishment of robust control strategies through data generation, method development, and design and execution of stability strategies.
- Collaborate with scientists across development and manufacturing and with external partners to design and implement control strategies for projects at various development stages.
- Evaluate and/or implement new analytical technologies/methods to advance analytical capabilities.
- Spearhead initiatives to improve scientific processes within the organization and across the company.
- Identify and apply new scientific concepts and problem-solving skills across multiple projects.
- Demonstrate strong written and verbal communication of technical and business implications of work.
Qualifications
- Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, or related field; or MS with 5+ years of experience; or BS with 10+ years of experience.
Additional Skills/Preferences
- Experience with analytical control strategy development from pre-FHD to commercial launch.
- Proven experience in drug development for cell and gene therapy products.
- Experience with chromatographic separations (RP, ion exchange, size exclusion), capillary electrophoresis, spectroscopic methods, and other analytical methods for cell and gene therapy products.
- Knowledge of ddPCR, ELISA, and cell-based bioassays for analysis.
- Effective oral and written communication skills and leadership abilities.
- Proficiency in multiple analytical technologies (chromatography, mass spectrometry, optical spectroscopy, instrument engineering) and data interpretation tools (chemometrics, multivariate modeling).
- Learning agility and ability to apply knowledge to improve chemical systems or analytical techniques.
- Ability to balance multiple activities, prioritize evolving project needs, and handle ambiguity; able to work in an interdisciplinary team.
Education
- Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, or related field; or MS with 5+ years of experience; or BS with 10+ years of experience.
Additional Requirements
- Travel: 0 to 15%
- Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)