Senior Manager - Analytical Method Validation

The Position

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

This role provides technical leadership and hands-on scientific guidance to ensure that analytical methods are validated in compliance with applicable regulatory guidelines (ICH, USP, and other compendial requirements), are fit for purpose, and are reproducible during routine testing. The successful candidate will serve as a technical subject matter expert (SME) and represent QC in cross-functional and external partner discussions.

Responsibilities

• Plan, author, and execute analytical method validation protocols and reports in accordance with internal SOPs, ICH Q2(R2) and related guidelines.
• Lead technical transfer of analytical methods between sites, laboratories, and contract partners, ensuring methods remain robust, reproducible, and fit for purpose in the receiving lab.
• Oversee validation and transfer activities for a broad range of analytical techniques supporting oligonucleotide purity and impurity testing. including Identity.
• Present and discuss method validation strategies, data, and technical rationale with internal stakeholders (Quality Assurance, Regulatory Affairs, Manufacturing, Analytical Development) and external partners (CDMOs, CROs, and other collaborators)
• Work independently with Analytical Development and manufacturing team to lead project timelines and deliverables.
• Serve as Analytical Project Coordinator or coordinate for on-going or new Analytical Validation and technical transfer projects, take ownership of analytical requirements needed, and provide accurate analytical results
• Support analytical methods of optimization and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient) and drug product.
• Provide hands-on troubleshooting support for method performance issues, out-of-specification (OOS) and out-of-trend (OOT) investigations, and root cause analysis.
• Serve as a technical resource for complex oligonucleotide characterization and impurity profiling questions.
• Evaluate new analytical technologies and methodologies to improve method robustness, efficiency, and data quality.
• Ensure timely and compliant documentation within the Quality Management System (QMS), including deviations, change controls, and CAPAs related to method validation
• Ability to track/trend data and interpret degrative changes to the product on
• Demonstrate proficiency with various related analytical techniques, such as LCMS, HPLC/UPHPLC, GC, FTIR, UV/Vis, KF.
• Design and execute non-routine experiments.
• Analyze data/results and interpret outcome of experiments and propose appropriate follow-up
• Write project documentation (i.e. Analytical test methods, developmental reports and protocols)
• Performs technical data review on data acquired by other QC analysts as applicable
• Other duties as assigned

Requirements

• M.S. in Chemistry (or related field) with at least 6+ years of relevant laboratory experience, or B.S in Chemistry (or related field) with at least 8 years of laboratory experience.
• Direct experience and working knowledge of various related analytical techniques, such as including Identity by LC-MS, Anion Exchange Chromatography (AEX), Ion-Pair Reversed-Phase UHPLC (IP-RP UHPLC)., Gas Chromatography (GC), Nuclear Magnetic Resonance (NMR), Fourier-Transform Infrared Spectroscopy (FTIR), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Raman Spectroscopy.
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices
• Demonstrated hands-on experience with analytical methods for complex oligonucleotides, including purity and impurity characterization.
• Proven track record of leading or executing method validation and technical transfer activities in a GMP-regulated environment.
• Experience supporting regulatory inspections and health authority interactions related to analytical methods is highly desirable.
• Strong leadership, coaching, and team-building skills.
• Highly organized with the ability to manage multiple projects and priorities simultaneously.
• Proficiency with chromatography data systems (e.g., Empower, OpenLab) and LIMS is a plus.
• Strong working knowledge of ICH guidelines on analytical method validation (ICH Q2(R2), Q14) and USP General Chapters.
• Can be flexible with changing priorities

Wisconsin pay range 140000 - 160000 USD