Senior Manager, Analytical Method Validation

The Analytical Method Validation Sr. Manager is responsible for leading a team of scientists in Quality Control (QC) to plan, execute, and oversee analytical method validation and technical transfer activities for complex oligonucleotide in-process, finished drug substance and drug product, and/or stability testing.

• Plan, author, and execute analytical method validation protocols and reports (internal SOPs, ICH Q2(R2) and related guidelines).
• Lead technical transfer of analytical methods between sites, laboratories, and contract partners.
• Oversee validation/transfer for analytical techniques supporting oligonucleotide purity/impurity testing (including Identity).
• Present method validation strategies, data, and rationale to internal and external stakeholders (QA, Regulatory Affairs, Manufacturing, Analytical Development; CDMOs/CROs).
• Lead project timelines and deliverables with Analytical Development and Manufacturing.
• Coordinate analytical validation and technical transfer projects; own analytical requirements and provide accurate results.
• Optimize/improve methods across API and drug product stages.
• Troubleshoot method performance issues; support OOS/OOT investigations and root cause analysis.
• Serve as a technical resource for oligonucleotide characterization and impurity profiling.
• Evaluate new analytical technologies to improve robustness, efficiency, and data quality.
• Ensure compliant QMS documentation (deviations, change controls, CAPAs related to method validation).
• Track/trend data and interpret degradative changes.
• Perform technical data review of QC analyst data.

• M.S. Chemistry (or related) + 6+ years; or B.S. Chemistry (or related) + 8+ years.
• Direct experience with analytical techniques (e.g., Identity by LC-MS, AEX, IP-RP UHPLC, GC, NMR, FTIR, ICP-MS, Raman).
• Familiar with analytical instrumentation, validation, data acquisition systems, and cGMP.
• Hands-on experience with analytical methods for complex oligonucleotides (purity/impurities) and a track record in GMP method validation/technical transfer.
• Regulatory inspection/health authority interaction experience desirable.
• Strong leadership, organization, and ability to manage multiple priorities.
• Knowledge of ICH Q2(R2), Q14 and USP General Chapters; flexibility with changing priorities.
• Proficiency with chromatography data systems (e.g., Empower, Open Lab) and LIMS is a plus.

• Wisconsin pay range: $140,000-$160,000 USD.

• Candidates must have current, valid authorization to work in the country where this role is located.