Jobs at KBI Biopharma

Lead and supervise analytical and formulation testing projects, including method development, validation, transfers, compendial verification, and stability/release testing for non‑GMP and GMP products. Manage project teams, review and produce regulatory-quality documentation, support product and formulation development, ensure cGMP and SOP compliance, and mentor junior staff while handling staffing and operational responsibilities.

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.

Lead business development across the UK and Benelux to identify, qualify, and close biopharmaceutical customers. Develop territory strategy, leverage networks, manage RFPs and proposals, negotiate contracts, coordinate site visits, legal and quality processes, maintain CRM, attend trade shows, and support VP of Business Development to expand existing accounts and secure new partnerships.

Lead MS&T operations for tech transfer, process validation, and support labs at the Durham manufacturing site. Manage multidisciplinary engineering and scientific teams, coordinate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to enable successful clinical and commercial product introductions, ensure cGMP compliance, support PAI, drive standards and process scale-up, recruit and develop talent, and represent the department in audits and cross-functional leadership meetings.

The Associate Scientist executes downstream process development and technology transfer while ensuring compliance with cGMP standards. Responsibilities include documentation, data analysis, and technical support for manufacturing processes.

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.

Lead and manage analytical development for early-phase biologics programs: develop strategies, oversee method development/qualification, troubleshoot investigations, coordinate cross-functional teams, produce regulatory-quality reports, and mentor junior staff to support rapid progression to early clinical manufacturing.

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.

The Senior QA Specialist reviews and approves Deviations and CAPAs for GMP manufacturing, mentors staff, and collaborates to streamline processes.

The Principal QA Specialist ensures compliance of Biopharmaceutical GMP data, oversees lab activities, and supports product lifecycle while collaborating with various stakeholders.

Manage global marketing campaign calendar, governance, and vendor/budget performance. Build HubSpot assets, enforce processes, track KPIs, optimize marketing tools, and enable cross-functional teams in a biopharma environment.

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.

Perform and interpret protein analytical experiments, lead LC-MS and chromatography method development, support qualification/validation and stability studies, generate regulatory-grade documentation, act as SME for client programs, collaborate cross-functionally, mentor junior staff, and manage project timelines and peer review of analytical data.

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.

Perform routine microbiology laboratory testing and support for a contract manufacturing biotech facility, including environmental, clean utility, compressed gas, and product testing; execute protocols, document results, troubleshoot, and follow safety and regulatory requirements.

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.