Working knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment preferred. MiniTab, JMP) preferred.Įquivalent combinations of education, training, and relevant work experience may be considered.Īpplied knowledge from the experience of applying the principles, concepts, and practices of discipline.
Xcalibur thermo software#
Experience using advanced statistical software packages and experience with design of experiments (DoE) software (i.e.
With Master's degree, no experience required related industry experience preferred. With Bachelor’s degree, minimum of 2 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory. Helps to maintain laboratory and order common supplies.Įxecutes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.īachelor's degree or Master’s degree in biology, chemistry, biochemistry, chemical engineering, or a related field. Maintains and ensures safe laboratory environment and work practices. Records results in notebook accurately, clearly, and regularly.Īssists with preparing protocols, reports, and test methods. Works with Process Development and Manufacture groups to trouble-shoot process challenges. Hands on experience using Chromeleon, Xcalibur, and/or Empower 3.Īssists with the design of experimental plans based on the defined deliverables.Ĭonducts moderately complex tasks and sample analyses to support process development. Knowledge and experience with protein characterization including peptide mapping and glycan analysis.
Multi-Attribute Method (MAM), LC-MS, and/or LC-MS/MS experience is preferred. Knowledge and experience with analytical chromatography (HPLC and/or UPLC) and assays including reversed phase, size exclusion, affinity, and/or ion exchange. Makes details observations and reviews, documents, and communicates test results. Develops, qualifies, and transfers analytical methods. Performs complex analytical methods and studies to support method and formulation development, structural characterization, comparability, forced degradation and other development activities of biopharmaceuticals at all stages of clinic development. Provides complex analyses in an analytical development laboratory using within defined procedures and practices.
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