Jobs at KBI Biopharma

Oversees Drug Substance and Drug Product Fill/Finish services, managing client relations, project timelines, team leadership, and financial aspects while ensuring project quality and compliance.

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.

Write and edit detailed technical proposals and project plans for contract process development, analytics, and GMP biotherapeutics manufacturing. Collaborate with cross-functional SMEs to define scope, schedule, costs, and deliverables; ensure accuracy of pricing and timelines; manage RFI/RFP responses and a centralized knowledge database; represent KBI in client meetings; and meet proposal deadlines while maintaining quality and alignment with internal standards.

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

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.

Conducts laboratory experiments for biopharmaceutical development, supports manufacturing testing, performs data analysis, maintains safety standards, and updates scientific knowledge.

The Associate Scientist will support analytical testing for biopharmaceutical manufacturing, perform cGMP testing, and document results. Responsibilities include troubleshooting, reviewing methods, and ensuring compliance with safety procedures.

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.

Lead and supervise analytical and formulation projects, oversee method development/validation/transfers and stability testing, ensure cGMP and regulatory-compliant documentation, manage and develop team members, coordinate cross-team and client interactions, and support product, process, and formulation development efforts.

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.

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

The Process Development Associate executes lab studies, documents findings, conducts experiments in support of process development, and maintains laboratory equipment compliance.