In this role, the individual is expected to perform optimization studies to support development of commercial processes for the manufacture of lead drug candidates. He/She is also expected to design and develop radiosynthetic routes for preparation of radiolabeled drug candidates being evaluated during pre-clinical investigation.
Education and Experience:
- Optimization and corresponding scale up of radiosynthetic processes.
- Development of radiosynthetic processes for production of radiolabeled drug candidates.
- Recording data on laboratory notebook, logs and/or batch record in accordance to cGXPs.
- Development and generation of applicable Standard Operating Procedures (SOPs) and technical reports.
- Providing technical support to CMOs as needed.
- Ph.D. degree in chemistry with 2+ years of experience in radiopharmaceutical research and/or development.
- Experience in organic chemistry applied to small molecule labeling is required.
- Working knowledge of HPLC and related analytical techniques such as LC/MS, GC, and NMR is required.
- Demonstrated ability to work independently in a highly focused manner.
- Strong organizational skills.
- Excellent written and verbal communication skills.
- Ability to travel as needed.
- Experience with pharmaceutical cGMP/GLP, ICH, FDA guidelines is desirable.
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