Separation Specialist

WuXi Biologics; Wuppertal; On-site; EUR 48,000 - 72,000; Full time

Job summary

WuXi Biologics in Germany seeks a QC Analyst to perform routine testing of release, stability and in-process samples per SOPs and cGMP. You will document experiments in LIMS, trend data, and assist in investigations and change controls, while supporting procurement and lab readiness.

The role requires a BS or MS in a related field and prior GMP QC experience is a plus, with hands-on use of HPLC/UPLC and UV techniques in a regulated environment.

Qualifications

• BS or MS in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another related field.
• Prior experience in a Quality Control/GMP environment is a plus.

Responsibilities

• 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.

Skills

cGMP knowledge

SOP authoring

Analytical testing

Education

BS or MS in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or related field

Tools

HPLC

UPLC

CE

cIEF

UV

Job description

• 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.