Separation Specialist

• 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.
• 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.