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.
Requirements:
- MS in Chemistry (or related) with 2+ yearsβ 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 pmβ11:30 pm (MonβThu); includes 10% shift differential.
Pay: $80,000β$100,000 (Wisconsin pay range).
Application: Candidates must have current, valid authorization to work in the country where the role is located.