Perform and coordinate analytical testing for functional group (Finished Products, Stability, Raw Materials), and reviews raw data generated in accordance with GMP guidelines.
- B. S. in Chemistry preferred, Minimum B.A. in Chemistry or related science.
- 7+ years in GMP pharmaceutical chemical analysis.
Expert in pharmaceutical analytical techniques and test methods.
- Must be able to work and problem solve independently and as part of a team.
- Must be able to train/mentor with detailed understanding on stability process, GLP/GMP and current FDA regulations.
- Fluent in HPLC, GC, FT/IR, UV/VIS and specialty equipment.
- LIMS, Documentum, Empower are positives.
- Computer literate and is able to use Microsoft Office software (Word, Excel, Powerpoint, Visio, etc)