Analytical Development Scientist / Chemist

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

Analytical Development Scientist / Chemist to support analytical method development, validation, and laboratory activities for Active Pharmaceutical Ingredients (API) and Finished Products in a GMP-regulated pharmaceutical environment.

The role involves developing, executing, and documenting analytical methods to support product development, stability studies, validation, and regulatory compliance, with strong hands-on experience in HPLC, Gas Chromatography (GC), and analytical laboratory techniques.

Key Responsibilities:

• Support the methods development, validation and verification to test new products manufactured at the site.
• Prepare and execute validation protocols and generate technical reports.
• Review and audit analytical data from development, validation, stability, and registration lots.
• Develop, prepare, and execute analytical and cleaning method validation protocols and summarize results in validation reports.
• Participate in analytical method transfer activities to commercial quality control laboratories, including data interpretation and troubleshooting during method transfers.
• Perform audit and critical review of analytical data generated during method development, validation, confirmation, registration lots, and stability studies.
• Investigate analytical deviations and support root cause analysis.
• Ensure compliance with FDA, USP, ICH, and cGMP requirements.
• Work independently with minimal supervision and support business-driven schedules.

Technical Expertise

• Analytical method development and validation for assay, dissolution (IR & ER), blend uniformity, and content uniformity .
• Analysis of impurities and degradation products .
• Residual solvents analysis by Gas Chromatography (GC) .
• Particle size analysis methods.
• Water determination (Karl Fischer) .
• Development and execution of cleaning validation analytical methods .

Experience with analytical instrumentation such as:
HPLC, GC, GC-MS, FT-IR, NMR, HRMS, dissolution systems, particle size analyzers, and Karl Fischer titration is required.

Qualifications:

• Bachelor's or Master's degree in Chemistry.
• Minimum 5 years of experience in a cGMP-regulated analytical laboratory
• Strong knowledge of GMP, ICH guidelines, and analytical validation requirements
• Experience working with API and finished pharmaceutical products
• Proven experience in method development, validation, cleaning validation, and method transfer.
• Strong data interpretation and documentation skills.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.