Separation Specialist
WuXi Biologics
Primary Job Objectives
- Perform routine testing of release, stability and in-process samples according to relevant SOPs, AMPs, protocols and cGMP requirements, including but not limited to separation methods.
- Document experiments following GDP and enter the results in LIMS.
- Trending of routine testing data including release, stability and in-process data.
- Participate in investigations, deviations and change control as needed.
- Help in procurement of lab reagents, standards and consumables.
- Participate in 5S activities and keep the lab in Audit ready mode.
- Complete regular training activities within timelines in MC.
- Perform analytical method transfer, verification/validation and routine analysis using various analytical techniques; including but not limited to HPLC (Titer, CEX etc.) UPLC, CE, cIEF and UV.
- Author Instrument SOPs and analytical methods as needed.
Minimum Requirements
- BS or MS in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another related field.
- Previous experience in a Quality Control/GMP environment is a plus.
Special Knowledge
- Ability to accurately and completely understand and follow cGMP requirements.
- Ability to author SOPs, methods, protocols/reports is a plus.