Perform and coordinate analytical testing for functional group (Finished Products, Stability, Raw Materials), and reviews raw data generated in accordance with GMP guidelines.
1.Develops and writes SOP’s for laboratory staff for all tests and relevant equipment.
2.Perform and trouble-shoot USP, EP, BP and in-house assays using advanced analytical techniques / equipment, such as HPLC, TCD and FID GC, Fourier Transform IR, etc. Document on appropriate records, forms, logs and worksheets.
3.Review and disposition all test data for applicable test articles.
4.Develop and write analytical laboratory SOP’s.
5.Write and execute investigational protocols for analytical procedures.
6.Create new chemical specifications.
7.Serve as department liaison in the absence of laboratory manager.
8.Support OpEx and EHS&S initiatives.
9.All other duties as assigned.
10.Assume the responsibility for the GMP, ISO and Environmental Health and Safety procedure awareness and compliance within the respective area.
- 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)