- Location
- Verona, Wisconsin, United States · Verona, WI
- Department
- Manufacturing
- Seniority
- Entry
- Education
- Master
Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This 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
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.
