Analytical Method Transfer Specialist

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

For Analytical Method Transfer Specialist services in the Laboratory area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or a related scientific discipline.
• Five or more years of relevant experience in an FDA-regulated pharmaceutical, medical device, biotechnology, or combination-product laboratory environment.
• Shift: Administrative and a ccording to business needs.
• Experience in:
  • Analytical technologies such as HPLC or UPLC, GC, FTIR, UV-Visible spectrophotometry, balances, pH meters, microscopy, and associated sample-preparation equipment.
  • Transferring methods between internal sites or between a company laboratory and a contract laboratory.
  • Release, stability, assay, impurities or degradation products, residual solvents, physical testing, or cleaning-verification methods, based on project scope.
  • Supporting laboratory expansion, remediation, product transfer, audit readiness, or regulatory inspections.

The Personality Part:

• If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
  

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support development of analytical method transfer plans, transfer assessments, protocols, comparative-testing strategies, acceptance criteria, and final reports.
• Coordinate transfer activities between the transferring and receiving laboratories, including schedules, samples, standards, reagents, equipment, training, and documentation readiness.
• Execute or support approved transfer testing using current procedures, specifications, worksheets, and laboratory controls.
• Confirm that required equipment is qualified and calibrated and that assigned analysts are trained before protocol execution.
• Prepare samples, standards, reagents, solutions, mobile phases, and laboratory materials accurately and in accordance with approved methods.
• Operate qualified laboratory equipment and generate, process, review, and document analytical results.
• Compile and compare results from transferring and receiving laboratories against protocol acceptance criteria.
• Support analytical method verification, qualification, validation, revalidation, troubleshooting, and lifecycle activities associated with method implementation.
• Evaluate method performance characteristics included in the approved protocol and determine whether the receiving laboratory meets established acceptance criteria.
• Document deviations and protocol exceptions occurring during method-transfer activities and support timely resolution before study closure.
• Contribute technical information to laboratory investigations, root‑cause assessments, nonconformances, CAPAs, and change controls associated with transferred methods.
• Author and revise transfer protocols, reports, assessments, data summaries, procedures, worksheets, technical justifications, and supporting records.
• Maintain complete, accurate, contemporaneous, attributable, legible, and traceable laboratory records in the applicable paper or electronic systems.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top‑notch quality talent.We're FITS!