Gregory Culp Email & Phone Number

•A result-oriented R&D scientist with extensive laboratory experience in analytical development, materials characterization, chemical R&D and formulation support, and instrumentation. •Strong expertise in HPLC method development and validation.•Productive, independent researcher, delivering high quality scientific results in an effective and efficient manner.•Results-oriented. Strong teamwork and problem-solving skills. •Excellent oral and written communication.•Extensive formulation support experience with oral solid dosage, topical, suspension and sterile solution, lyophile and spray dried dispersions.•Extensive chemical R&D support experience with HPLC method development for in-process and drug substance analysis.•Hands-on experience with pre-formulation and formulation activities support, including drug characterization, stability, compatibility and cleaning validation, in-process testing and ICH stability studies.•Comprehensive knowledge of cGMP requirements.

San Diego, Ca

Assisted in the transfer of new and existing assays from Research & Development to Lab Operations.Optimized processes and procedures.Defined and confirmed product performance characteristics.Ensured robustness of manufacturing procedures.Established product stability claims.Automated sample prep for clinical test samples using Janus Liquid Handler.Performed process validation studies.Developed scalable processes with improved product yield and reduced costs for manufacturing.

Scientist I, Analytical DevelopmentDeveloped and validated analytical methods for new drug candidates. Supported Chemical R&D and Pharmaceutical R&D by performing in-process and stability testing, drug substance and drug product assay, and chiral purity determination. Developed and validated numerous HPLC methods for the assay, impurity analysis and chiral assay of drug substances and synthetic intermediates.Demonstrated teamwork and efficiency in working closely with chemists (CRD) and pharmaceutical formulators (PRD) to support tight timelines and meet project goals.Authored numerous validation protocols, reports, and analytical methods.Performed Gas Chromatography analysis for residual solvents.Utilized UPLC with MS detection to quantify trace impurities associated with new drug candidates.Provided cross-training and mentoring to analysts and student interns in HPLC analysis.

Developed and validated analytical methods for new drug candidates. Project work involved various solid dosage forms, suspensions, lyophile, and sterile solutions. Provided analytical support for pre-clinical and clinical drug studies.Provided analytical support for NDA submittal for Viracept (HIV protease inhibitor drug).Supported formulation development by performing in-process, stability and compatibility testing, and cleaning validation for oral solid dosage forms, suspensions, spray dried dispersions, lyophile and sterile solutions.Successfully developed and validated eight new HPLC methods for synthetic intermediates in 3 months to meet an aggressive project timeline for an oncology drug.Authored numerous validation protocols, reports, and standard test methods (STM).Developed Gas Chromatography methods for residual solvents.Utilized new technologies and LC/MS to rapidly screen up to six HPLC columns and several buffer systems for rapid method development, and to identify impurities associated with new drug candidates.

Provided analytical support for clinical trails and regulatory filing of monoclonal antibodies (MA). Served on various project teams, representing the analytical group.Developed HPLC methods for the analysis of MA and other pharmaceuticals.Validated analytical methods and instrumentation in compliance with cGMP regulations.Established system suitability test guidelines, and reference control value assignment.Established documentation for standard operating procedures and validation protocols.