Analytical Method Transfer Expert

FITS, LLC; Dorado (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

FITS, LLC is hiring an Analytical Method Transfer Specialist for our Laboratory team in the United States (Puerto Rico, Dorado region). The role focuses on planning, coordinating, and executing analytical method transfers between internal sites or contract laboratories, ensuring compliance with approved methods and regulatory expectations.

The candidate will manage transfer plans, training, documentation, and method verification activities, while supporting scale-up and lifecycle activities.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related field.
• Five+ years of relevant experience in an FDA-regulated pharmaceutical, medical device, biotechnology, or combination-product laboratory environment.
• Shift: Administrative and per business needs.
• Experience with analytical technologies and method transfer between internal sites or contract labs.

Responsibilities

• Develop and support analytical method transfer plans, protocols, and transfer reports.
• Coordinate transfer activities between laboratories, including schedules, samples, standards, reagents, and documentation.
• Execute or support transfer testing using current procedures and laboratory controls.
• Ensure equipment qualification and analyst training before protocol execution.
• Prepare samples, reagents, and materials per approved methods.
• Operate laboratory equipment and document analytical results.
• Compile results and compare against protocol acceptance criteria.
• Support method verification, qualification, validation, and lifecycle activities.
• Evaluate method performance and ensure receiving lab meets acceptance criteria.
• Document deviations and resolve protocol exceptions before study closure.
• Contribute to investigations, CAPAs, and change controls related to transferred methods.
• Author and revise transfer protocols, reports, data summaries, and supporting records.
• Maintain complete, accurate lab records in systems.

Skills

Method transfer

HPLC/UPLC

Lab analysis

Documentation

Education

Bachelor's degree in Chemistry or related field

Tools

FTIR

UV-Vis spectrophotometry

GC

pH meters

Microscopy

Job description

FITS, LLC is hiring an Analytical Method Transfer Specialist for our Laboratory team in the United States (Puerto Rico, Dorado region). The role focuses on planning, coordinating, and executing analytical method transfers between internal sites or contract laboratories, ensuring compliance with approved methods and regulatory expectations.

The candidate will manage transfer plans, training, documentation, and method verification activities, while supporting scale-up and lifecycle activities.