Senior Manager, Analytical Method Validation
Arrowhead Pharmaceuticals
September 03, 2026
Remote friendly (Madison, WI)
United States
Operations
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.
Responsibilities:
- 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.
Requirements:
- 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, OpenLab) and LIMS is a plus.
Compensation:
- Wisconsin pay range: $140,000–$160,000 USD.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- 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.
Requirements:
- 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, OpenLab) and LIMS is a plus.
Compensation:
- Wisconsin pay range: $140,000–$160,000 USD.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.