Senior Manager, Analytical Method Validation

Scorpion Therapeutics; Madison (WI); On-site; USD 140,000 - 160,000; Full time

Job summary

Scorpion Therapeutics in Madison, Wisconsin is seeking an Analytical Method Validation Sr. Manager to lead a QC team in method validation, transfer activities, and impurity testing for oligonucleotide products.

You will plan and execute validations per ICH Q2(R2) and related guidelines, present strategies to stakeholders, and drive project timelines across Analytical Development and Manufacturing. The role requires advanced chemistry degrees, GMP experience, and strong leadership to ensure

Qualifications

• M.S. Chemistry (or related) + 6+ years; or B.S. Chemistry (or related) + 8+ years.
• Experience with analytical techniques (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 GMP method validation/technical transfer.

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.

Skills

Leadership

GMP

ICH Q2(R2)

ICH Q14

USP General Chapters

LC-MS

UHPLC

LIMS

Empower/OpenLab

Education

M.S. Chemistry

B.S. Chemistry

Tools

Empower

OpenLab

LIMS

Job description

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.