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.

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.

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.

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.

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.