Job description:
JOB DESCRIPTION :
The Scientist will be responsible for laboratory activities for assigned projects, including but not limited to the following:
- Working on extractables/leachables and pharmaceutical impurity identification using advanced mass spectrometry techniques including LC/MS and GC/MS.
- Investigate analytical method performance, reliability and improvement issues, and evaluate proposed changes to compendial and in-house methods.
- Preparing technical documents, including validation protocols and reports, analytical test procedures and technical reports.
- Perform all required mass spectrometry experiments, including routine analysis, structure elucidation and quantitative method development and validation. Working on all analytical instrumentation, good knowledge in routine and non-routine maintenance.
- Make routine use of scientific literature and have a good understanding of the disciplines beyond chemistry and pharmaceuticals.
Role and Responsibilities :
- Operating mass spectrometry instruments and working on pharmaceutical analysis, including extractables/leachables, impurity identification/profiling, etc., for assigned projects.
- Perform LC/MS and GC/MS quantitative method development and execute method validation and method transfer to other laboratories.
- Prepare technical documents, including study protocols and reports, analytical test procedures, and technical reports. Prepare the necessary documentation for regulatory submissions as required.
- Ensure that the analytical procedures developed in the laboratory conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.
- Conduct investigations in the areas of method performance and reliability and evaluate proposed changes to compendia or developed methods under supervision.
- Prepare protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements under supervision.
Basic Qualifications :
- BSc degree in chemistry with strong experience in chromatography, mass spectrometry (LC/MS, LC/MS/MS, GC/MS) and other spectroscopic techniques.
- At least 3 years of experience in a mass spectrometry laboratory.
- Good knowledge in organic and analytical chemistry, including organic structure elucidation of small molecules by mass spectrometry.
- Strong written and oral communication skills, English language, and the use of MS Office (Word, Excel) are required.
Preferred Qualifications :
- MSc Chemistry
- > 5 years of mass spectroscopy experience.
- Experience with polymers and material selection for container closure systems or devices is a plus.