Separation Specialist

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.