Paul Herbert Email & Phone Number

Cambridge, Massachusetts

• Supported Vericel by performing assays integral to the manufacturing and lot release of patient specific products.
• Performed, authored, and reviewed Laboratory Investigation Reports, Deviation Reports, CAPAs, Risk As-sessments, and Change Controls as a lead investigator and manager reviewer.
• SME and Supervisory role for team of analysts performing cell culture based assays including scheduling, training, performance, troubleshooting, and communication of results at cross functional meetings.
• SME for the Carticel® foreign matter program and SME responsible for the development and implementation the MACI® foreign matter testing program.
• SME role for lot release assays including Viability, Minimum Cell Number and qPCR based ID and Potency assays.
• QC point of contact for scheduling and performance of stability and quarterly reference strain testing for mul-tiple products.

Frederick, MD

Supported SAIC Frederick/Leidos by overseeing the transfer of multiple analytical methods integral to novel vaccine production from the NIH, including authoring SOP’s, equipment specifications, performance qualifications, and analyzing samples for purity and contamination.

West Point, PA

• Support Vaccine Basic Research in the Surface Antigen Group. Design constructs of a wide range of microbial surface antigens to test for expression levels for use in the study of potential vaccine candidates. Perform.
• Provided time-critical support to ensure project deadlines were met or exceeded.
• Successfully trained co-workers for proficiency on running SBA.
• Collaborated on the SBA development and optimization in order to significantly increase assay reliability.
• Key contribution to two vaccine development programs.

West Point, PA

• Supported Merck Vaccine Basic Research in the Microbial Vaccine Group. Performed SBA with Neisseria meningitidis A, C, W135, and Y with assay development and optimization.
• Effectively developed and implemented ELISA to analyze dose dependent responses for various vaccine targets.
• Used human cell lines for growth of intracellular bacteria utilized in vaccine candidate challenge experiments.
• Performed assay functions in BSL2+/3 environment.

Exton, PA

• Performed in vivo pharmacokinetic studies in small animals including various methods of dosing, sampling, and analysis of data. Collaborated on the development and implementation of an ex vivo isolated rat liver.
• Supported the development of both native knock-down and recombinant knock-in of various transport proteins in mammalian cell culture lines employing various genetic and molecular techniques.
• Integral collaborator to drug discovery including solubility and formulation analysis of new compounds utilizing HPLC.
• Performed critical metabolic studies including CYP inhibition and induction utilizing LC/MS.

Master'S Degree, Biology

Thesis entitled “Differences in the Microbial Populations Between Halite and Brine at the Cabo Rojo Solar Saltern”

Bachelor'S Degree, Cellular And Molecular Biology