
Senior Methods Specialist, Analytical Technology Support
- Kansas
- $94,300-148,500 per year
- Permanent
- Full-time
- Lead and execute hands‑on method development and improvement activities at the bench across multiple bioassay platforms (e.g., ELISA, virus titration, HA/HI). Design experiments, run assays, analyze results, and implement technical fixes to improve accuracy, precision, sensitivity, and robustness.
- Plan and manage site‑to‑site analytical method transfers: develop transfer plans, perform parallel testing, document equivalency, troubleshoot discrepancies, and close transfer gaps to achieve successful adoption.
- Perform complex data analysis and trending to identify non‑robust methods and root causes; partner with data analytics and statistics to guide experimental design and acceptance criteria.
- Write and maintain technical documents to support transfers and development efforts, including protocols, SOPs, validation reports, and technical summaries suitable for QC and regulatory review.
- Lead cross‑functional project teams and coordinate with stakeholders across Quality Control, Operations, Bioprocess Technology Solutions, Regulatory Affairs, and Analytical Technology Solutions across five U.S. sites.
- Use internal systems to manage project plans, track milestones and risks, and report progress to site and regional leadership.
- Present technical findings, status updates, and risk‑mitigation plans to team, site, and regional stakeholders.
- Mentor and train QC staff on new or transferred methods to ensure reproducible implementation and ongoing compliance.
- Education Minimum Requirement:
- 3–5 years’ hands‑on bench experience developing, validating, and transferring analytical methods within a QC or analytical lab (in vitro bioassays emphasized).
- Demonstrated project management experience leading analytical method transfers and improvement projects across multiple sites.
- Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) with practical experience executing assays and troubleshooting instrumentation and assay performance.
- Proven ability to perform bioassay data analysis, trending, and interpretation; able to translate data into concrete technical actions and acceptance criteria.
- Strong technical writing skills for protocols, validation reports, and technical documentation.
- Proven cross‑functional collaboration skills, including experience working with QC, Manufacturing, Regulatory, and R&D teams and coordinating activities across multiple locations.
- Detail‑oriented, proactive, and able to balance bench‑level work with project leadership responsibilities.
- Experience with method development focused on USDA requirements and animal health processes.
- Familiarity with automated imagers, liquid handlers, and other analytical technologies used to scale and transfer methods.
- Experience designing experiments for bioassays and working with statistical acceptance criteria.
- Experience presenting technical data to cross‑functional stakeholders and leadership.
- Demonstrate execution excellence through effective problem-solving and critical thinking.
- Embrace an entrepreneurial mindset, taking initiative and ownership of their work.
- Adapt with agility and resilience in a dynamic, fast-paced environment.
- Uphold a safety-first mindset, ensuring the well-being of themselves and their colleagues.
- Embrace ambiguity and adapt with resilience.
- Be part of a transformative organization that will shape the future of animal health
- Work with a dynamic and experienced team
- Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products
- Help us meet growing global demand for our portfolio of animal health solutions
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: Temporary (Fixed Term)Relocation: No relocationVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: YesHazardous Material(s): N/ARequired Skills: Analytical Method Development, Analytical Method Transfer, Analytical Problem Solving, Assay Development, Collaboration, Communication, ELISA Techniques, ELISA Test, High-Throughput Assays, Laboratory Testing, Manufacturing Technologies, Method Development, Parallel Testing, Professional Presentation, Project Management, Protocol Development, Technical Transfer, Throughput Optimization, WritingPreferred Skills: Bioassay Design, USDA RegulationsJob Posting End Date: 09/19/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.