The PositionArrowhead Pharmaceuticals is seeking a Scientist I, Quality Control to join our growing Quality organization in Verona, Wisconsin. In this role, you will support analytical method validation, method transfer, and quality control testing for pharmaceutical raw materials, in-process manufacturing samples, drug substance, drug product, and stability studies across our innovative RNAi therapeutic pipeline.
This position offers the opportunity to work in a fast-paced GMP laboratory, applying advanced analytical techniques while collaborating closely with Analytical Development and Manufacturing. You'll serve as a technical resource within the laboratory, contribute to scientific problem-solving, and help ensure the quality and integrity of products advancing through development and commercialization.
This role is 2nd shift and eligible for a 10% shift differential.
Responsibilities- Perform analytical testing of raw materials, in-process samples, drug substances, drug products, and stability samples using validated analytical methods.
- Execute method validation, method transfer, and routine QC testing activities in accordance with cGMP requirements and ICH guidelines.
- Operate, troubleshoot, and interpret data from analytical instrumentation, including
- LC-MS
- HPLC/UHPLC (RP and AEX)
- Gas Chromatography (GC)
- Karl Fischer titration
- FTIR
- Endotoxin/LAL testing
- Raman spectroscopy
- Analyze and interpret analytical data, including stability trends and degradation profiles.
- Independently investigate analytical results and make sound scientific decisions while ensuring data quality and compliance.
- Collaborate cross-functionally with Analytical Development, Manufacturing, and Quality teams to support product development and manufacturing activities.
- Lead technical discussions, troubleshoot analytical challenges, and contribute to continuous process improvements.
- Train and mentor laboratory colleagues on analytical techniques, instrumentation, and laboratory best practices.
- Maintain accurate documentation in compliance with cGMP, Good Documentation Practices (GDP), and internal procedures.
- Support laboratory investigations, method improvements, and other Quality Control initiatives as needed.
Requirements- Bachelor's degree in Chemistry or a related scientific discipline with 5+ years of relevant laboratory experience, or Master's degree in Chemistry or a related scientific discipline with 3+ years of relevant laboratory experience.
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations.
- 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
$90,000-$108,000 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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