Our client is seeking a Scientist to join the CMC Analytics group, which performs/manages analytical development activities to support our products, intermediates, and starting materials.
- Independently develop new analytical methods and optimize existing analytical methods to meet our drug development needs.
- Manage external resources to perform method development, testing, and validation activities
- Review analytical protocol/report/result generated by internal/external personnel
- Follow established procedures to test quality attributes using various techniques, including but not limited to pH, osmometry, viscosity, UV, IR, IC, LC-MS.
- Participate in lab maintenance and coordination of instrumentation repairs/maintenance.
- Analyze, interpret, and present experimental data in multidisciplinary team meetings.
- Coordinate with process development, engineering, and biology team members to manage analytical workflow and ensure timely delivery of results.
- Maintain detailed records in electronic laboratory notebook following quality guidelines.
- Assist to manage technical transfers to CMOs
- BS/MS/PhD in chemistry or biology with an analytical concentration
- Minimum of 5 years of industry experience in pharmaceutical/biotechnology
- Extensive development and troubleshooting experience on chromatography & mass spectrometry
- Extensive experience working in a GLP/GMP environment
- Experienced with method qualification/transfer/validation following guidelines
- Experienced with drafting protocol/report and reviewing others
- Hands-on experience on light scattering and/or microscope techniques is preferred
- Working knowledge of biopolymers and/or medical devices is desired
- Able to take detailed notes and observations about experimental design, process, results, and analyses and to record those experimental results in both ELN and presentation format
- Able to mentor junior team members
- Able to set priorities and multi-task activities to effectively manage workflows and deliverables
- Great team player
- Good written and oral communication skills
- Must have the authorization to work in the United States