Jobs at KBI Biopharma

The QA Specialist II ensures compliance through reviewing and approving GMP data, method qualifications, validations, and laboratory investigations in biopharmaceutical development.

The Microbiology Senior Associate conducts testing and support in the Microbiology Laboratory for a biotechnology facility, focusing on environmental monitoring, product testing, and method development.

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.

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.

Design and govern enterprise data architecture for SAP S/4HANA, lead migration strategy and validation frameworks, establish data standards and governance, support profiling/cleansing and tooling selection, partner with business and technical stakeholders to ensure migrated data supports reporting, compliance, and analytics.

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 Program Manager leads complex client portfolios, manages relationships and expectations, ensures program delivery is on time and within budget, and supports PMO initiatives and process improvements.

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

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

The Senior Research Associate/Data Reviewer will conduct data reviews for analytical programs, ensuring accuracy and compliance with standards while collaborating with supervisors.

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.

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, qualification, validation, transfers, compendial verification, release and stability testing (non‑GMP and GMP). Coordinate cross‑team efforts, interact with clients, produce high‑quality regulatory documentation, maintain cGMP compliance, provide technical leadership, and support lab organization and safety.

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.