Lead Analytical group to develop product specific assays for the routine testing and characterization of Revance products. Train QC personnel on new methodologies and participate in the transfer and qualification of these methods. Participate in teams responsible for troubleshooting existing assays. Lend support to the characterization efforts for Revance products and support development activities occurring within other groups at Revance. Participate various regulatory submissions by authoring & reviewing relevant sections.
• Regularly apply basic theory and principles from one’s expertise in biochemistry, separation and mass spectrometry technologies to develop, optimize, and transfer analytical assays for lot release and stability testing.
• Lead efforts to develop new assays for additional characterization.
• Supervise the technical transfer of assays to and from contract test laboratories.
• Lead analytical team in method development, qualification and validation.
• Ownership of the writing of development reports and test methods.
• Support other groups within Revance Development and Manufacturing by testing samples.
• Expected of spending at least 50% time in the lab doing various studies and providing help.
• Working knowledge of cGMP requirements and ICH guidelines.
• Experience in the development, and optimization of assays, solid technical training and troubleshooting experiences are required.
• Experience in various modern analytical assay disciplines including mass spectrometry
• Previous cGMP experiences, as well as experience working with QC groups.
• Excellent interpersonal and communication skills in a team-oriented environment are required.
• Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.
• Proficient written and verbal communication skills are required.
• Ph.D. in Biology or Chemistry with at least 5 years in a variety of biophysical and separation assay techniques.
Preferred Additional Skills (i.e., Computer):
• Proficient with Microsoft Word and Excel
• Proficient in Empower software (Waters Corp)