Keith Oberg Email & Phone Number

San Diego Metropolitan Area

Insulin & Fluid-Path Materials ScienceAnalytical chemistry / CMC for pump submissionLeader in insulin chemistry, responsible for maximizing integrity and stability of insulin infused from insulin pumps and infusion sets.

Greater Los Angeles Area

CREATIVE solutions for Diagnostics and Medical Device startupsSpecializing in Troubleshooting, Biomolecules, Materials, Drug-Device CompatibilityFeasibility Studies, Verification Testing, DVT, Shelf-Life, BiocompatibilityGrants, Regulatory Submissions, and early-stage project managementMultiple successful IDE submissions and over $3M in grant awards

Valencia California

Managed and implemented product roadmap for monolith technology platform Managed intellectual property portfolio & patent submission Managed collaborations and OEM development agreementsCreated new materials for Diagnostics and Next Gen. Sequencing productsLeveraged Lean Startup and 3D printing to rapidly optimize and deliver prototype products.

Valencia, California

Member of think-tank / business intelligence teamCreated platform technology leading to spin-out of Monolythix Inc.Evaluated and created intellectual property Established and managed collaborations with external thought leaders Lead benchtop technical feasibility evaluationsAdvised marketing, I.P., grants, and management on candidate technologies

Greater Los Angeles Area

Drug delivery with fully implantable infusion pumps. Primary Responsibility: medication compatibility and biocompatibility of implanted pump under cGMPWorked under ISO13485, ISO14971, CFR 21 Pt. 211Led drug compatibility program from start through IDE approvalAuthored/managed submitted reports and responses to FDA Guided device design and process.

Greater Los Angeles Area

Primary function: Technical lead of Advanced Technosphere Research group. Secondary function: Analytical Chemistry Manager in California location.Founded Analytical Chemistry and Advanced Technosphere Research teams Established theoretical framework for Technosphere-insulin interactions leading to patents and manufacturing process improvements for Afrezza®.

Insulin Stability & Compatibility with implanted delivery system

Postdoc in the laboratory of Anthony Fink. Focused on protein aggregation. Performed characterization of pharmaceutical proteins in collaboration with industry. Also studied protein aggregation and established analytical methods for the characterization of aggregation. Mentored Graduate Students.

Postdoc in the Laboratory for Physical Chemistry of Macromolecules at Interfaces (L.C.P.M.I., Jean-Marie Ruysschaert and Erik Goormaghtigh)Developed spectroscopic structure analysis methodology for proteinsDeveloped processing algorithms for raw spectrum data processing, and chemometrics, especially PLS, PCA and cluster analysis. Studied/published.