Jobs at KBI Biopharma

The role involves creating and maintaining production schedules, optimizing operations, coordinating with various teams, and reporting on metrics. The candidate will ensure alignment with manufacturing needs and feedback processes.

The IT Systems Specialist II provides advanced technical support, manages system configurations, network support, and software deployment, while also handling user account management and collaborating with vendors.

The role involves creating and maintaining production schedules, optimizing resource efficiency, and ensuring alignment across departments to support production goals.

The Senior Analytical Scientist will design experiments, mentor junior staff, and provide technical expertise in analytical testing and method development for biotherapeutics.

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.

Lead site CAPEX projects from requirements through deployment, managing scope, schedule, budget, risk mitigation, cashflow forecasting, and governance. Coordinate cross-functional teams and vendors, report outcomes and risks, ensure cGMP/GxP compliance, and provide technical decision-making. Manage and develop staff, oversee onboarding/training, and maintain stakeholder communications using MS Project, MS Planner, and Power BI.

Lead analytical method development and qualification for biotherapeutics, using protein analytics and biophysical techniques to support formulation, stability, and regulatory submissions. Serve as SME, mentor junior staff, collaborate across functions, generate high-quality documentation, and manage project timelines and technical risk.

Support departmental and global analytics by performing financial analysis, metric tracking, capacity modeling, forecasting, budget preparation, proposal/change order review, and cross-functional reporting to inform decision-making.

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.

The Process Development Scientist II leads and executes laboratory studies for microbial process development, documentation, technology transfer, and mentoring junior staff, ensuring compliance with cGMP standards.

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.

Lead and direct analytical and formulation sciences for biologics across development to commercialization. Oversee scientific strategy, lab operations, budgets, client engagement, regulatory compliance (GMP), and multidisciplinary teams to deliver high-quality analytical data, implement formulation technologies, and drive operational and financial performance in a CDMO environment.

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.

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 Manufacturing Quality Assurance Specialist supports the manufacturing process, ensures compliance, guides manufacturing teams, and executes core QA activities including record review and resolution of deviations.

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

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.

Perform analytical in-process and release testing (HPLC, SDS-CGE, ELISA, qPCR, SoloVPE, compendial USP), prepare solutions, analyze and trend data, support method transfers/qualifications/validations, investigations, CAPA, metrics, audit readiness, trainer qualification, and provide onsite laboratory support (≥75% onsite).