Brian Stuart Email & Phone Number

Salt Lake City, Ut, Us

Lehi, Utah, United States

In my role as Sr Manager Analytical R&D for Civica, I oversee analytical research and development to support the drug development of pharmaceuticals from pre-clinical development through commercialization. Lead R&D projects in support of product development, scale up, and ANDA filings. Oversight of product, analytical, formulation, validation, and scale up development. Responsible for activities at contract testing labs in support of method establishment. Manage GMP batch release, stability, and additional studies to support ANDA regulatory filings. Oversight and management of contract development and manufacturing organizations supporting development and scale up for parenteral and OSD products. Author regulator sections in ANDA filings and provide support for correspondence with regulatory agencies. Develop specifications and justifications in support of API, excipients, drug product, and components.Business development and contract preparation for development, vendor, and supply chain partners. Identify, evaluate, and contract with organizations to advance development projects, file regulatory applications, and manufacture approved products. Evaluate development contracts, quality agreements, master service agreements, quotes and proposals against organizational goals and resources to maximize long-term performance.

Salt Lake City, Utah, United States

In my role as Manager R&D for Teva, I performed and managed analytical method development, validation, method transfer, and various research in support of pharmaceutical product development, submission, and commercial applications. My main areas of expertise were in method development, optimization, validation, cleaning verification, and peak identification primarily using HPLC, UPLC, GC, GC headspace, GC-MS, and LC-MS. I am well versed in FDA requirements as well as ICH, USP/NF, data integrity, cGLP, and cGMP principals.

Greater Salt Lake City Area

Manage a team team responsible for: analytical method development, validation, testing, research, technical investigations, deficiencies, troubleshooting, data interpretation, report generating and review for pharmaceutical products including: transdermals, topical gels, creams, raw materials, and solid dosages. Prepare, develop, and present research data to peer groups. Perform research and help prepare documents in support of CMC filings. Part of team efforts to determine and develop scope, nature, and format of new and revised SOPs. Strict compliance to SOPs as well as ICH, USP/NF, cGLP and cGMP guidelines.

Greater Salt Lake City Area

Analytical method development, validation, testing, research, technical investigations, deficiencies, troubleshooting, data interpretation, report generating and review for pharmaceutical products including: transdermals, topical gels, creams, raw materials, and solid dosages. Prepare, develop, and present research data to peer groups. Perform research and help prepare documents in support of CMC filings. Part of team efforts to determine and develop scope, nature, and format of new and revised SOPs. Strict compliance to SOPs as well as ICH, USP/NF, cGLP and cGMP guidelines.

Responsible for a variety of sample collection and testing to assure water quality. Required to perform analysis, calibration, and maintenance on analytical instrumentation. Tasked with creating proper documentation and report generation for adherence to federal and state regulations.

Master Of Business Administration (Mba), Business Administration And Management, General

Bachelor'S Degree, Chemistry