Lauren B. Gilvey Email & Phone Number

Cary, Nc, Us

Cary, Nc, Us

United States

Template designer for the Process Development Electronic Lab Notebook systems

Morrisville, North Carolina, United States

United States

Analytical Development

Provide analytical support to fermentation, recovery, and downstream during process characterization (includes Bradford, SDS-PAGE, Western Blots and RP-HPLC Assays).

Participate in the start-up activities of the Quality Control laboratories as well as develop the laboratory testing systems.* Participate in the technical transfer of assays from the Novartis site in Marburg, Germany including the BCA, SDS-PAGE, DNA Threshold, Neuraminidase and SRD assays* Write site-wide standard operating procedures for activities such as the generation of stability protocols, laboratory cleaning, and the operation of the RO and Milli-Q water systems* Procure laboratory equipment and supplies* Develop an internal method for tracking equipment procurement, delivery, and validation activities within the biochemistry laboratory* Develop and monitor equipment calibration schedules* Validate laboratory equipment per ICH guidelines* Create instrument operating procedures as well as the supporting logbooks* Develop test method standard operating procedures along with the supporting laboratory test records and training requirements* Establish the laboratory layout and develop the assay flow organization* Interview and assist in the hiring laboratory personnel* Initiate the technical transfer of biochemistry test methods.* Develop expertise on the Novartis Single Radial Diffusion assays at Liverpool, Marburg and Siena* Observe bioassay testing procedures at the Novartis Vaccine Liverpool siteProvide support for various departments as needed.* Provide technical support for the H1N1 vaccine campaign at the Liverpool site* Perform EM monitoring during PQ testing* Establish and schedule pipettor training for the Holly Springs site* Procure equipment for glass wash validation* Author SRAs and SCFs for equipment in other labs as needed* Train personnel on SRAs and SCFs

Participate in developing methods for identification and characterization of proteins or antibodies in the analytical development group, as well as provide analytical support to groups such as cell culture, purification, and formulation. Utilize both electrophoretic and chromatographic methods to determine product titer and purity in support of cell culture harvest and purification eluates.

Protein Chemistry: 2003-2008Responsible for the spectroscopic characterization of the function and mechanism of the enzyme dehaloperoxidase hemoglobin (DHP-HB) from the marine worm Amphitrite ornata. Nanoparticle delivery to cancer cells: 2003Explored the delivery of modified gold nanoparticles to HeLa, 3T3/NIH and HepG2 cells. DNA Micro-Array: 2002 Used fluorescently labeled single-stranded DNA to characterize a DNA micro-array, and optimize hybridization conditions.

Analytical Chemistry: August 2005 – December 2007 Instructor for the third and fourth year analytical chemistry laboratory.General Chemistry: August 2001- May 2005Laboratory and tutorial instructor to the first and second semester general chemistry students.

Assisted the veterinarians in all aspects of medicine and surgery, including sterile procedures and laboratory testing. Helped to establish staff training programs, and developed client education materials and handouts. Additional responsibilities included inventory management and staff scheduling. Also developed and maintain the hospital webpage (parkwayanimal.com).

Masters Of Science, Chemistry

Bachelors Of Arts, Theatre