Mike O'Mara

Salesforce Cloudflare DNS Outlook Microsoft Office 365 CloudFlare Hosting Google Tag Manager YouTube Gravity Forms reCAPTCHA WordPress.org Vimeo Mobile Friendly Remote

cell therapy manufacturing cart nkcells analytical development process development manufacturing preclinical to commercial cdmo expertise program mangement fda experience pai experience supply chain tcells tech transfers validation eqms fda audits quality control quality assurance cell banking mscs hscs feeder cell banks fibroblasts dendritic cells tils fill finish stability testing gap analysis scale up feasibility runs process verification autologous allogeneic patient first improving patient lives purpose built facility innovative technology building partnerships business development dmso nondmso biotechnology research cell therapy cdmo cgmp manufacturing clinical manufacturing quality compliance allogeneic cell therapy car-t services ipscs exosomes process optimization clinical trials patient access autologous therapies regulatory support cell culture cryopreservation viral vector t-cell therapies stem cell processing manufacturing infrastructure supply chain management analytical method development biotechnology partner drug product manufacturing cell therapy development potency assay modular cleanroom automated processing systems cryogenic storage patient-centric solutions laboratory services cell isolation viability testing gene transfer clinical product development stability studies process validation fill-finish services in-process control environmental monitoring documentation management risk mitigation real-time pcr mechanical or industrial engineering b2b health care health wellness & fitness hospital & health care logistics & supply chain