Jobs at KBI Biopharma

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.

Review and verify analytical method development and qualification data for biopharmaceutical in-process and drug substance/product samples. Ensure calculations, documentation, and analyses follow SOPs, test methods, and cGMP/regulatory requirements. Maintain understanding of assays and laboratory instrumentation and support continuous compliance and assigned tasks.

The role involves reviewing data and documents for compliance, accuracy, and completeness, including providing feedback and support for technical writing of reports and protocols.

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.

The Senior Automation Engineer manages automation systems, supports compliance, leads projects, and ensures systems are maintained according to engineering and quality standards.

Assists the site EHS&S Head in implementing environmental, health, safety, and sustainability programs. Manages hazardous waste, wastewater, emissions, resource monitoring, environmental indicators, equipment, consumables, service-provider contracts, and regulatory improvements. Participates in incident investigations, risk management, LOTO, confined-space entry, industrial hygiene, hazard communication, PPE, emergency management, and engineering-control initiatives. Coordinates with departments and operations to mitigate risks and maintain 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.

Lead and coach shop-floor continuous improvement in a GMP biomanufacturing site. Facilitate Kaizen and problem-solving events, perform time-and-motion studies, develop standard work and visual management, track value capture, and support governance and performance systems to sustain the KBI Business System.

Lead a small PM team and act as primary client/account manager for assigned portfolios. Oversee project lifecycles, schedules, budgets, contracts, risk mitigation, cross-functional team alignment, client communications, and PMO process ownership. Provide mentorship, support strategic client discussions, and assist proposal/change order development while ensuring GMP-aligned delivery.

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.

Leads business development for biopharmaceutical services by identifying prospects, developing client relationships, soliciting and managing RFPs, presenting capabilities, coordinating technical visits, negotiating agreements, and closing contracts. Maintains CRM opportunities, supports strategic partnerships and collaborations, coordinates with scientific, legal, quality, marketing, and management teams, and monitors biopharmaceutical industry opportunities. Requires travel to client sites, company facilities, trade shows, and scientific meetings up to 50% of the time.

Execute and document process development lab experiments (fermentation, chromatography, filtration, etc.), troubleshoot, maintain equipment, author basic operational documents, support process improvements, ensure compliance and safety, and work rotating/off-hours shifts as needed.

Support the Computer Systems Validation lifecycle: author protocols, test scripts, execute testing, analyze/verify data, and write summary reports. Maintain validation archives, ensure compliance with 21 CFR Part 11 and EU Annex 11, support change controls, deviations, CAPAs, and audit responses, and coordinate validation for equipment and software systems.

The Director of Business Development focuses on acquiring new biopharmaceutical clients and expanding existing relationships, negotiating contracts, attending trade shows, and ensuring strategic alignment to meet business objectives.

The Process Development Associate executes laboratory studies, supports process development, maintains laboratory compliance, and drives operational improvements under supervision.

Lead QC microbiology programs including environmental, compressed gas, product testing, media release, and lab support. Oversee method verifications, troubleshooting, data analysis, documentation, regulatory compliance, training, and safety for laboratory operations. Provide technical leadership and may perform testing as needed.

This role involves identifying and developing biopharmaceutical business opportunities, managing client relationships, closing contracts, and coordinating business development activities.

The Process Engineer III will optimize and support manufacturing processes by leading projects, ensuring compliance with regulations, and collaborating with cross-functional teams in a biotech environment.

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.

Perform and analyze bioassays (cell-based assays, ELISAs), run plate-reader and flow cytometry assays, maintain multiple cell lines aseptically, troubleshoot experiments, record data per cGMP/GLP/GCP, and communicate results in notebooks and presentations.