Scientist II, Quality Control
$105,000–$120,000 year
On-siteVerona, Wisconsin, United States
Job Summary
Lead analytical method validation, method transfer, and quality control testing for raw materials, in-process samples, drug substances, and stability programs. Independently manage project timelines while partnering with Analytical Development, Manufacturing, and cross-functional teams to drive scientific decision-making and mentor junior scientists. Design, execute, and interpret complex experiments to support process development and product lifecycle activities, ensuring full compliance with cGMP and ICH guidelines. Perform technical reviews of analytical data, support out-of-specification investigations, and prepare documentation including validation protocols, SOPs, and scientific presentations. Assist in optimizing analytical methods across API and drug product development phases.
Required Qualifications
- Bachelor's degree in Chemistry or a related scientific discipline with 8+ years of relevant laboratory experience
- Master's degree in Chemistry or a related scientific discipline with 5+ 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
- 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
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