Associate Scientist III, Quality Control; 2nd shift

Responsibilities

• Perform in-process control (IPC) sample receipt, preparation, and testing per approved methods/SOPs for defined IPC sample lanes (e.g., crude pool, post-purification pool, post-UF/DF intermediate, final strand/duplex release).
• Execute analytical techniques including LCMS, AEX and RP-HPLC purity/identity testing, UV (A260) concentration/assay, Karl Fischer water content, pH, and bacterial endotoxin (LAL) testing.
• Record raw data, calculations, and results in real time in compliance with good documentation practices (GDP).
• Support investigations (OOS, OOT, deviations) by providing accurate data, reviewing raw data trends, and performing confirmatory/re-test work.
• Monitor sample hold times; promptly communicate any hold-time risk, atypical result, or equipment issue impacting batch progression.
• Maintain a clean, organized, GMP-compliant lab bench/work area (including 5S).
• Communicate effectively during shift handoff to ensure continuity of testing and batch status.

• MS in Chemistry (or related) with 2+ years’ relevant regulated laboratory experience, or BS in Chemistry (or related) with 5+ years in a GMP QC/analytical laboratory.
• Strong attention to detail and GDP; ability to work against hold times/turnaround targets.
• Prior experience testing oligonucleotides/peptides/synthetic biomolecules.
• Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, and/or LAL/endotoxin testing.
• Experience with in-process (real-time) testing in a manufacturing-adjacent QC lab.
• Knowledge of cGMP and ICH laboratory requirements; proficiency with analytical instrumentation and test method validation/transfers.

Shift: 2nd shift, 1 pm–11:30 pm (Mon–Thu); includes 10% shift differential.

Pay: $80,000–$100,000 (Wisconsin pay range).

Application:
Candidates must have current, valid authorization to work in the country where the role is located.