Mathew Mathai

About Mathew Mathai

A resourceful and highly knowledgeable pharmaceutical leader, with extensive experience in managing multiple projects in end-to-end project life cycles, including product development, analytical development, and regulatory filings. Excels Drug substance, Excipients, and Commercial Drug Products release for Marketed products. Excels at method development, regulatory compliance, troubleshooting and crisis resolution, project management, and reporting and documentation. Applies keen skills across the pharmaceutical industry, leading impactful products from development into final ANDA submission. Emphasizes efficiency and accuracy in managing day-to-day operations in the name of developing a suite of impactful products. Proven success in empowering goal-oriented research through effective planning and management. Staff Development | Quality Control | Stability Oversight | Data Analysis Technology Transfer | Process Improvement

Experience

1. Manager Ad Qc

   I3 Pharmaceuticals, Llc

   Jul 2025 — Present

   Oversaw and managed drug substances, Excipients, drug products for QC release, and the generic drug product method development stage through ANDA filing, including solid orals, oral solutions, and oral suspensions.• Managed, led, and mentored QC and R&D teams. Provided continuous feedback to commercial, Stability, and product development teams on formulations.• Managed, led, and mentored Lab Technicians daily to maintain the housekeeping and Daily Calibration Verifications for the balances, pH Meters, and Lab chemical inventory.• Managed Stability monitoring, loading, and pulling samples from stability chambers for Commercial and ANDA projects. • Provided continuous feedback on commercial annual Stability to RA teams and ANDA stability samples to product development teams.• Reviewed product development reports, submission batch protocols, reports, LIR, CAPA and performed Lab investigations.• Supervised, trained, and led a team of Twelve scientists to perform analytical QC/R&D operations for Commercial release, method development, method validation, release testing, and stability testing for drug substances, drug products, and excipients.

Education

• SJM College of pharmacy, Karnataka, India

  Bachelor of Science - BS, Pharmacy, Pharmaceutical Sciences, and Administration

  1990 — 1995

• SSS College of Pharmacy

  Diploma in Pharmacy, Pharmacy

  1988 — 1990

Skills

• Analysis
• Regulatory Submissions
• Research
• Uv-Vis
• Analytical Methods Development
• Analytical Chemistry
• Uv/Vis
• Pharmaceutics
• Qc
• Quality Assurance
• Impurities
• Chromatography
• Anda
• Quality System
• V&V
• Analytical Techniques
• Chemistry
• Pharmaceuticals
• Ich Guidelines
• Analytical Method Validation
• Tlc
• Wet Chemistry
• Cleaning Validation
• Quality Control
• Gmp
• Compliance
• Ir
• Gas Chromatography
• Hplc
• Validation Reports
• Method Transfer
• 21 Cfr Part 11
• Dissolution Testing
• Dissolution
• Karl Fisher
• Ph Meter
• R&D
• Validation
• Method Development
• Andas