Jobs at KBI Biopharma

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 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.

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 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.

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.

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

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.