Methods Transfer - Validation Specialist

The <\/span span>Methods Transfer - Validation Specialist <\/span span b>is responsible for planning, executing, and documenting analytical method transfers, validations, verifications, and method improvement initiatives in compliance with regulatory requirements. This role ensures analytical methods are robust, reproducible, and suitable for their intended use across internal and external laboratories. The specialist collaborates closely with Quality Control, R&D, Manufacturing, and third party testing laboratories to support product lifecycle and regulatory submissions.

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Key Responsibilities<\/span span b>

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Method Transfer<\/span span b>

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Coordinate and execute analytical method transfer activities between sending and receiving laboratories span>

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Prepare method transfer protocols and reports in accordance with internal SOPs and regulatory expectations span>

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Provide technical training and support during method transfer execution span>

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Investigate and troubleshoot discrepancies during or after method transfer span>

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Method Validation & Verification<\/span span b>

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Develop method validation strategies aligned with ICH, FDA, EMA, USP, and other relevant regulatory guidelines span>

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Draft and review validation protocols, including risk assessments and acceptance criteria span>

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Perform statistical data analysis and ensure methods meet parameters such as accuracy, precision, specificity, linearity, robustness, and detection limits span>

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Prepare method validation reports and ensure completeness and traceability of documentation span>

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Analytical Support<\/span span b>

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Serve as a subject matter expert (SME) for analytical methodologies span>

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Provide analytical troubleshooting and technical support for routine and non -routine testing span>

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Evaluate and implement method improvements or optimizations to enhance method performance span>

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Requirements<\/h3>

Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.

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Five years of experience in a regulated industry (pharmaceutical, biotech, or medical devices) in analytical development or quality control laboratory.

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Experience conducting method transfers and validations required.

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Technical writing and documentation ability.

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Bilingual (Spanish/English)(Write/Speak)

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