Jobs · Analyst · Wisconsin

Associate Scientist III, Quality Control (2nd shift)

Arrowhead Pharmaceuticals · Madison, WI · 3 wk ago
On-siteAnalyst$80k/yrFull-time

About the role

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using RNA interference (RNAi) technologies, Arrowhead therapies induce rapid, deep, and durable knockdown of target genes. This position is within the Quality Control structure, supporting GMP manufacture of oligonucleotide antisense strand (AS), sense strand (SS), and duplex drug substance (DS), as well as stability sample testing for new drug substances and drug products.

This hands-on bench role executes analytical testing (e.g., LCMS, HPLC, UV, Karl Fischer, pH, bioburden/endotoxin) during second shift operations to ensure timely, accurate results for real-time batch disposition decisions. The role requires close coordination with Manufacturing personnel and reports to QC Laboratory Management.

Schedule

2nd shift work hours are 1:00 PM – 11:30 PM, Monday - Thursday, with 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 including 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.
  • Work both independently and collaboratively in a dynamic environment.

Requirements

  • Master’s in Chemistry (or related field) with 2+ years’ relevant laboratory experience in a pharmaceutical/regulated environment or Bachelor’s 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.
  • Candidates must have current, valid authorization to work in the country where this role is located.

Pay

Wisconsin pay range: $80,000 USD - $100,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

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