Senior Lead, Oligonucleotide Method Validation & Transfer

Scorpion Therapeutics

Madison (WI)

On-site

USD 140,000 - 160,000

Full time

9 days ago

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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.