Alex Bilogur

About Alex Bilogur

More than 20 years of experience in GMP/GLP environment including 12 years in management role.· Thorough understanding of pharmaceutical quality systems, project management, analytical methods validation, materials/vendors qualification, investigations/CAPA, global regulatory and compendial submissions, audits, GMP and GLP regulations, and USP/NF, EP, JP, BP, ICH guidelines.· 9 years experience of working under Consent Decree and developing quality systems according to CD requirements.· Expertise in Methods Development, Validation, Transfer and Compendial Methods Verification.· Expertise in packaging components, raw materials, in-process bulks, finished products, water, cleaning validation and cleaning monitoring testing.· Expertise in investigations/deviations management.· Extensive knowledge and hands-on experience with HPLC, GC, TLC, UV-VIS, IR, Raman, AA, CE, KF, TOC, dissolution, potentiometric titration and other analytical instrumental methods. · Advanced computer skills, including in-depth knowledge of TrackWise, SAP/CAPA, GxPharma, Labware LACES/LIMS, GDMS, MS Office, various enterprise level collaboration tools, as well as laboratory data acquisition systems, such as Agilent Chemstation, Waters Millennium/Empower, PE Turbochrom, CDAS, etc.· Exceptional communication, presentation, and project management skills.

Experience

1. Sr Manager, Global Quality, Analytical Science & Technology

   Bristol Myers Squibb

   Mar 2014 — Present · New Brunswick, NJ, US

Education

• Saratov State University

  Master's degree, Biology; Biology and Chemistry Education

  1978 — 1983

Skills

• Quality Management
• Regulatory Requirements
• Uv/Vis
• Cleaning Validation
• Process Analytical Technology
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Pharmaceutical Industry
• Sop
• Fda
• U.s. Food and Drug Administration (Fda)
• Laboratory Information Management System (Lims)
• Glp
• Change Control
• Leadership
• Hplc
• Six Sigma
• Standard Operating Procedure (Sop)
• Chemistry
• Capa
• Analytical Method Validation
• Pharmaceutics
• Chromatography
• Vaccines
• Analytical Chemistry
• Cross-Functional Team Leadership
• Quality System
• Product Development
• Technology Transfer
• Corrective and Preventive Action (Capa)
• R&D
• Microbiology
• Validation
• Laboratory
• Biopharmaceuticals
• Lims
• Good Laboratory Practice (Glp)
• Uv/Vis Spectroscopy
• 21 Cfr Part 11