Senior Analytical Development Scientist - Method Transfer

Merck & Co.

Madison (WI)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

FUJIFILM Cellular Dynamics is seeking a Senior Analytical Development Scientist in Madison, WI to lead analytical development activities across multiple programs. You will transfer and qualify analytical methods, collaborate with R&D and tech teams, and ensure regulatory compliance through ICH, USP, ISO, and FDA guidance.

The role requires strong technical leadership and mentorship within a cross-functional setting.

Qualifications

PhD or equivalent with required years of related experience.
Experience leading method qualification and validation-readiness efforts with risk-based analytical strategies.
Experience transitioning methods from development to QC.
Proficiency with flow cytometry, PCR, and ELISA in a multidisciplinary setting.

Responsibilities

Lead analytical development activities for multiple internal and external programs.
Develop, transfer, and validate analytical methods across teams and clients.
Provide technical leadership for qualification and lifecycle strategies; establish acceptance criteria.
Apply ICH, USP, ISO, and FDA guidance to ensure compliance.
Lead technology transfer and support IND submissions; drive project objectives.
Prepare documentation, reports, SOPs, and presentations; communicate findings.