Analytical Chemist Job Summary:
The analytical chemist is responsible for designing and conducting analytical testing to support research and development projects in the field of drug delivery including sustained release, targeted drug delivery, microspheres, nanoparticles and solubility enhancement. This position reports to Analytical Manager.
- Develop and validate analytical methods.
- Design and execute laboratory experiments and interpret analytical data
- Perform analytical testing for new product development using instruments such as HPLC, GC, UV-Vis Spectrometer, Fluorescence Spectrometer, Dissolution, Particle Size, and KF titrator.
- Write technical documents such as SOPs, test methods of analysis, design development plans and release and stability protocols and reports.
Essential Job Functions:
- Develop, validate and transfer analytical methods for drug substance, drug product and residual swabs (e.g. related compounds, assay, dissolution, residual solvents, TOC, etc.)
- Able to design and execute experiments and interpret analytical data.
- Design method transfer, verification and validation protocols and author reports.
- Perform routine analytical tests of pharmaceutical raw materials, in-process samples, finished products, and stability samples using instrumentation such as HPLC, GC, UV/VIS, dissolution apparatus, particle size analysis, etc.
- Responsible for the timely execution of lab analysis and related documentation of all raw data, record observations in templates/notebooks. Peer review of analytical data.
- Interact with formulations R&D group, understand and participate in progress of the project.
- Identify and troubleshoot analytical problems with instrumentation, general chemistry, and computer applications.
- Mentor laboratory technicians, junior scientists as well as interns.
- Adhere to safety, FDA procedures, and department SOPs.
- Prepare and review documents including method of analysis, specifications, SOPs, protocols and reports.
- Perform other duties as assigned.
Requirements and Qualifications:
- Bachelor of Sciencein Chemistry, pharmacy, pharmaceutical sciences or related discipline with a minimum of 2-8 years of experience. Master of Science or Ph.D. preferred.
- Experience in pharmaceutical analytical laboratory with an active role in the development and validation of chromatography, spectroscopy and wet chemistry methods
- Strong analytical skills with instruments such as HPLC, UPLC, GC, UV/VIS, Fluorescence, LCMS, dissolution apparatus, particle size analysis, etc.
- Well versed with Microsoft Office applications.
- Understanding of FDA, ICH, and regulatory guidelines and knowledge of cGMP and/or GLP practices preferred.
Please submit all resumes to: firstname.lastname@example.org