Eastern GMP Consulting, LLCVerified

I am a seasoned pharmaceutical/biotech professional with over 30 years of experience in the space. Throughout this time in the industry, I have lead and supported my organization's CMC (Chemistry, Manufacturing, and Controls) operations/MSAT, supply chain operations, purchasing and R&D operations both internally and externally, and have been responsible for leading my organization's 3rd party vendor operations, which includes CDMOs/CMOs partners, contract clinical and commercial packaging vendor partners, CROs, contract laboratories and laboratory supply and laboratory equipment vendors, our manufacturing and packaging equipment vendors, all of our bioprocessing consumables and single-use equipment suppliers, our validation, calibration, repair, and our environmental and temperature monitoring solution providers, all of our cold chain logistics and container suppliers, our serialization and track & trace and supply chain management software solution providers, contract commercialization service providers, hub services and market access partners. Additionally, my experience and expertise spans upstream and downstream to other areas of my organization's supply chain partners, which includes cold chain logistics and 3PL service providers, API suppliers, raw materials and excipients, all starting materials, and packaging component suppliers, and packaging and manufacturing equipment suppliers that feed into manufacturing, packaging, and laboratory operations. I also lead and direct the evaluation, RFP, and selection processes of new vendors and am one of the final decision makers, lead the audits, the contract negotiations, the implementation and technology transfers for new vendors, and the daily project/program management and operations management of our key vendor partners in these spaces.