The PositionThis position is within the Quality Control structure, under the Quality Organization. An Associate Scientist III, Quality Control, IPC Testing performs in-process control (IPC) and release testing supporting GMP manufacture of oligonucleotide antisense strand (AS), sense strand (SS), and duplex drug substance (DS), and/or stability sample testing activities for new drug substances and drug products. This role executes analytical testing (e.g., LCMS, HPLC, UV, Karl Fischer, pH, bioburden/endotoxin) during second shift operations, ensuring timely, accurate results are delivered within sample hold times to support real-time batch disposition decisions. This is a hands-on bench role requiring close coordination with Manufacturing personnel across the shift. This position reports to QC Laboratory Management.
2nd shift work hours are 1 pm - 11:30 pm, Monday - Thursday, and includes a 10% shift differential.
Responsibilities
- Perform IPC sample receipt, preparation, and testing per approved analytical methods and SOPs at each defined IPC sample lane (e.g., crude synthesis pool, post-purification pool, post-UF/DF intermediate, final strand/duplex release)
- Execute analytical techniques which may include LCMS, AEX and RP-HPLC purity/identity testing, UV (A260) concentration/assay, Karl Fischer water content, pH, and bacterial endotoxin (LAL) testing.
- Accurately record raw data, calculations, and results in laboratory notebooks, forms, and/or batch records in real time, in compliance with good documentation practices (GDP).
- Participate in investigations (OOS, OOT, deviations) by providing accurate data, reviewing raw data trends, and executing confirmatory/re-test work as assigned.
- Monitor and comply with sample hold times; communicate promptly with Manufacturing and QC leadership regarding any hold-time risk, atypical result, or equipment issue that could impact batch progression.
- Maintain a clean, organized, and compliant lab bench and work area in accordance with GMP, safety, and 5S expectations.
- Communicate effectively with first-shift QC/Manufacturing staff during shift handoff to ensure continuity of testing and batch status.
- Ability to work both independently and collaboratively in a dynamic environment
- Demonstrates enduring flexibility and understanding with changing
Requirements- Masters in Chemistry (or related field) with 2+ years' relevant laboratory experience in pharmaceutical/regulated environment or Bachelors in Chemistry (or related field) with 5+ years in a GMP QC or analytical laboratory environment.
- Strong attention to detail and good documentation practices; comfort working against defined hold times and turnaround targets.
- Prior experience testing oligonucleotides, peptides, or other synthetic biomolecules.
- Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing.
- Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab.
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations
- Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices
Wisconsin pay range
$80,000-$100,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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