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.
Duties include:
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.
Education and Experience:
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.
