Jobs 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.

Lead and execute downstream process development, characterization, and technology transfer for microbial processes. Design and run experiments for chromatography, TFF, and filtration unit operations, produce regulatory-quality documentation, support cGMP manufacturing and deviations, and implement downstream process improvements. Serve as technical SME and support training and safety compliance.

Leads downstream-focused technology transfer, process engineering ownership, and manufacturing facility support for biologics programs. Serves as a subject matter expert in drug substance operations, reviews technical and validation documents, develops solutions, supports 24/7 manufacturing operations, and coordinates cross-functional teams. The role also manages project resources, influences adjacent departments, and acts as a primary technical client contact.

Client-facing Quality Assurance specialist supporting pharmaceutical product release, deviation investigations, CAPA reviews, complaints, audits, inspection readiness, and cGMP compliance. Acts as the liaison between internal Quality teams and clients, leads quality activities for projects, communicates batch status and quality metrics, supports regulatory interactions, and completes Annual Product Quality Reviews. The role requires cross-functional collaboration, quality decision-making, and reporting across global networks.

Lead design and delivery of cloud-based, data-centric software platforms for biopharma. Develop, maintain, and review data analysis tools, work with SMEs, own projects end-to-end, mentor engineers, and promote best practices and digital transformation.

Execute and troubleshoot analytical experiments on biotherapeutics using HPLC, mass spectrometry, electrophoresis, ELISA and biophysical methods; analyze and document data in technical reports and electronic lab notebooks; present results to internal teams and clients; maintain safety and continuous improvement in lab processes.

Develop and write technically detailed proposals and project plans for biotherapeutic process development, analytics, and GMP manufacturing. Collaborate with cross-functional SMEs and BD to define scope, schedules, budgets, and deliverables; manage proposal workflow, client meetings, RFIs/RFPs, and a centralized knowledge database. Ensure accuracy, quality, and timely delivery of proposals aligned to KBI standards.

Execute and document process development laboratory studies, serve as operational lead on projects, maintain lab systems as SME for 1-2 unit operations, troubleshoot equipment, author operational documents, drive process improvements, and ensure training and quality compliance.

Perform analytical testing and method qualification of biotherapeutic samples (HPLC, SDS-PAGE, SDS-CGE, ELISA, UV-Vis), execute protocols, analyze and document data, troubleshoot experiments, present findings, maintain lab safety, and collaborate with cross-functional teams and clients.

Design, build, and operate AWS-based cloud platforms and Amazon EKS Kubernetes environments. Implement Infrastructure-as-Code (Terraform), CI/CD and GitOps pipelines, monitoring/observability, security controls, and self-service platform capabilities. Partner with compliance, security, and engineering teams to support GMP and non-GMP workloads, incident response, and continuous platform improvements.