Methods Transfer - Validation Specialist

About the role

The Methods Transfer - Validation Specialist plans, executes and documents analytical method transfers, validations, verifications and method improvement initiatives in compliance with regulatory requirements. The role ensures analytical methods are robust, reproducible and suitable for their intended use across internal and external laboratories, working closely with Quality Control, R&D, Manufacturing and third-party testing laboratories to support product lifecycle and regulatory submissions.

Key responsibilities

• Coordinate and execute analytical method transfers between sending and receiving laboratories, preparing protocols and reports per internal SOPs and regulatory expectations, and provide technical training and support during transfer.
• Investigate and troubleshoot discrepancies during or after method transfer.
• Develop method validation strategies aligned with ICH, FDA, EMA, USP and other guidelines, draft and review validation protocols including risk assessments and acceptance criteria.
• Perform statistical data analysis and verify methods meet accuracy, precision, specificity, linearity, robustness and detection limits.
• Prepare validation reports and keep documentation complete and traceable.
• Serve as a subject matter expert for analytical methodologies, provide troubleshooting and technical support for routine and non-routine testing, and evaluate and implement method improvements.

Required profile

• Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or a related discipline.
• Five years of experience in a regulated industry (pharmaceutical, biotech or medical devices) in analytical development or quality control laboratory.
• Experience conducting method transfers and validations.
• Bilingual (Spanish/English), write and speak.

Required skills

• Technical writing and documentation.
• Statistical data analysis for method validation.

What we offer

• Opportunities for learning, development and professional growth.
• A collaborative and supportive work environment.
• The chance to work with industry-leading clients on impactful projects.