Teams at KBI Biopharma

Conduct and oversee protein analytics by LC-MS and related techniques for biotherapeutic development, regulatory submissions, and commercialization. Design analytical experiments and strategies, review method development and validation data, prepare regulatory-quality documentation, advise clients and leadership, manage project milestones, and mentor junior scientists. Serve as a mass spectrometry subject matter expert while collaborating with process development, characterization, and regulatory teams.

Performs analytical testing for biopharmaceutical manufacturing, including in-process, product release, stability, and cGMP testing. Supports stability trending, troubleshooting, laboratory investigations, method and protocol review, technical reporting, and accurate documentation. Interprets experimental data, contributes to project goals, ensures compliance with safety procedures, and supports quality activities in a contract development and manufacturing environment.

Leads the Boulder site's Operational Excellence strategy and a global portfolio of Lean, Six Sigma, continuous improvement, and transformation initiatives. The role develops OpEx capabilities, coaches leaders, manages cross-functional projects, establishes performance metrics, drives process standardization, supports digital and AI-enabled improvements, and delivers measurable operational and financial results. This director also leads culture transformation, capability-building programs, risk management, reporting, and sustained adoption across a GMP-regulated biopharmaceutical environment.