Robert Kent Email & Phone Number

Accomplished professional with extensive experience in the pharmaceutical industry. Strong understanding of manufacturing, testing processes, and quality systems. Demonstrated proficiency in chromatographic methods development and validation. Especially skilled at resolving complex analytical issues. Excellent analytical and problem solving skills. Extensive working knowledge of laboratory data system implementation and validation.> Over 15 years experience at leading groups responsible for the development, validation, and transfer of analytical analysis methods for pharmaceutical compounds using the latest equipment and techniques.> Responsible for designing and outfitting a new QC laboratory at an API manufacturing facility. The FDA subjected this laboratory to several general and PAI inspections without any observations.> Proven expertise in the development and validation of analytical methods for pharmaceutical compounds using HPLC, GC, GC-MS, LC-MS, IC, CE, and TLC.> Directed the analytical evaluation of GLP test articles as the Principal Investigator of formulation analysis.> Skilled at auditing manufacturing facilities, laboratories (internal/external), CROs, and raw material suppliers to ensure compliance with all SOPs, GMPs, and GLPs.> Led the validation effort of a laboratory data and LIMS system that was installed and validated at manufacturing sites throughout the world.Specialties: AREAS OF EXPERTISE* All Chromatographic Techniques* Internal / External Audits* GMP and GLP Compliance* Development and Validation* OOS Investigations* IT Management* Laboratory Management* GLP Principal Investigator* Product Release / Stability* Cleaning Validation Procedures* FDA Inspections* Project & Budget Management

Listed skills include Gmp, Validation, Glp, Pharmaceutical Industry, and 12 others.