John Gilbert Email & Phone Number

Greater Savannah Area

Vernon Hills, Il

Direct the daily operations of a 30 – 35 member multi-site analytical chemistry, microbiology and clinical manufacturing team delivering innovative solutions and products. Execution of development activities achieved through strong science, bold strategic planning and integration of cross-functional teams and resources.• Delivered pharmaceutical/medical device projects on time, within budget and meeting quality objectives through strategic planning, scientific acumen, attracting/developing/ retaining talent, cross-functional leadership and team collaboration.• Realized $1.25M annualized savings in each of the last 8 years through evaluation, selection and management of development work conducted internally vs. externally at multiple global contract research partners. • Transitioned the Product Development Group from El Paso, TX to Skokie, IL to Vernon Hills, IL over a two year period while maintaining project timelines, budget and quality.• Directed teams delivering clinical trial materials to support over fifty clinical and GLP studies over the last 8 years.• Developed and mentored associates to excel in current role and advance into leadership roles within the company.• Demonstrated track record moving programs into late-phase development (Ph. 2b – 3) and then through commercialization; Led discussions to terminate programs for safety, quality, efficacy, manufacturability or business direction.• Actively directing teams in supporting >10 programs in topical anti-infective technologies, biosurgery, advanced repair & reconstruction and combination device kitting.• Led cGMP phase-appropriate activities including method development/validation/transfer, clinical/non-clinical material manufacture, product analysis, specification setting and authorship and review of regulatory filings including Chemistry, Manufacturing and Control and other sections for both US and international registrations (IND, NDA, ANDA, PMA, 510k, IDE).

El Paso, Texas, United States

Led the daily operations of a 20-person analytical chemistry/microbiology team responsible to delivering innovative solutions and products in support of reducing healthcare-associated infections (HAIs). • Led formulation and analytical efforts for the approval of the ChloraShield® 510k submission March 2011.• Directed IND supportive formulation and analytical development efforts to support of two IND submissions for next generation anti-infective combination products.

St Louis, Missouri, United States

• Grew revenue from $1.5M to $7.5M (2007 – 2009) with an EBTA of >25%. • Led two successful business acquisitions Cyanta Analytical Laboratories and ADMEQuant Bioanalytical Services.

Rtp, Nc

• Counseled customers about optimal solutions to their development programs.• Developed project scope and plans to execute programs for $100M in work resulting more than $45M in contracted work.

Morrisville, Nc

• Directed the efforts of 25 – 35 technical professionals providing analytical chemistry support to pulmonary and nasal product development driving annual revenues of >$7M with EBTA of 25 – 35%.• Directed laboratory programs in support of IND, NDA and ANDA customer programs for more than 15 products. Activities included development, validation, transfer, regulatory writing and execution of product characterization studies.• Other roles: Associate Director Inhalation Development (1999 – 2002); Sr. Scientist 2/Sr. Manager (1997 – 1999); Scientist 2/Group Leader (1995 – 1997); Scientist 1/Group Leader (1993 – 1995)