وظائف شاغرة لدى ادوية الحكمة

Job Description

• Responsible for analytical method development for extractable and leachable testing by GC-FID-MS, LC-UV-MS.
• Responsible for structural elucidation for unknown extractable, leachables, and other unknowns in drug products.
• Responsible for developing semi-quantitative and quantitative chromatographic and mass spectrometric methods for extractable and leachables.
• Responsible for assisting other laboratories on method development, optimization, validation and trouble shooting.
• Generates documents in support of regulatory submissions.
• Effectively communicates in technical documents or at team meetings. Participates in cross departmental project teams as required.

Skills

• Must have significant knowledge and experience with mass spectrometry: LC-MS, GC-FID/MS and HPLC. Experience with ICP-MS is a big plus.
• Has a working knowledge of quantitation using mass spectrometry.
• Has a working knowledge of structural elucidation using mass spectrometry.
• Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements is highly desired.
• Understanding of industry guidance provided by the FDA, ICH and USP relating to extractables and leachables.
• Understand of the industry guidance provided by regulatory agencies on nitrosamines. .

Education

PhD or master’s degree in analytical chemistry or closely related field.