Jobs at Fresenius Kabi

Lead budgeting, forecasting, and monthly financial analysis for North America. Execute advanced analytics and automation (Python, R, SQL, Power Query), maintain ERP and planning systems (SAP, TM1, P20, BCS, FKGAN), prepare management presentations, support month-end close, and coach junior staff.

Manage daily rebate operations and payments in Model N; mentor rebate analysts; reconcile deductions in SAP; produce ad hoc and standard reports; support audits and contract administration; act as Model N SME and collaborate with Sales, Finance, and National Accounts to ensure compliance and process improvements.

The Director of Procurement Operations oversees Source to Pay activities, leads transformation initiatives, manages supplier relationships, and ensures compliance with procurement standards. This role engages with stakeholders and drives operational excellence.

Oversees business process development and enhancement, focusing on quality improvement, cost reduction, efficiency increase, and compliance. Responsibilities include applying process methodologies, documenting requirements, and implementing quality assurance protocols.

Execute procure-to-pay activities in SAP: convert requisitions to purchase orders, manage PO changes and confirmations, maintain vendor master data, track deliveries, resolve routine supplier issues, support requestors on P2P tools, meet SLAs, and support continuous improvement and compliance documentation.

Analyze contract compliance and performance, prepare commercial and customer analyses, support contract setup and changes in Model N, monitor contract performance, assist audits and reconciliations, and collaborate with contract operations, marketing, sales, and account teams.

Serve as first point of contact for MedTech product quality complaints in North America. Log and manage complaints in the Global Complaint Management Workflow, collect documentation and samples, coordinate returns and investigations with Post Market Quality Assurance, provide timely customer communications and credit authorization, produce reports for commercial teams, attend review meetings, escalate issues, and support compliance with FDA and company quality systems.

Serve as the primary customer-facing contact for MedTech product quality complaints in North America. Triage, document, and manage complaint workflow in gCMW; coordinate sample retrieval/returns, collaborate with Post Market Quality Assurance and commercial teams, provide status updates and final evaluation letters, authorize credits when applicable, and support investigations and reporting to ensure regulatory compliance and customer satisfaction.

Lead analytical development for extractables and leachables (E&L): develop/validate methods, perform mass spectral interpretation and unknown identification, operate and troubleshoot GC/MS and LC/MS systems in a cGMP environment, prepare protocols/reports and regulatory summaries, mentor junior scientists, and communicate results across cross-functional teams.

Lead the Extractables & Leachables team ensuring compliant study execution, technical evaluation, and collaboration with product development teams to support regulatory submissions.

Support aseptic filling operations by measuring KPIs, applying Lean tools, managing small capital projects, coordinating vendors and contractors, creating specifications and risk assessments, and driving shop-floor continuous improvement within cGMP guidelines.

The Senior Manufacturing Engineer leads mentoring efforts, aligns engineering teams with business strategies, and drives continuous improvement across manufacturing operations.

Manage and supervise microbiology laboratory teams across Environmental Monitoring, Finished Products, Aseptic Mentor, and Methods Validation groups. Oversee staffing, training, gowning/aseptic qualification, testing programs, investigations, validations, SOPs, and cGMP compliance to ensure timely product release and quality performance.

Administer and analyze medical rebate programs, ensure contractual and financial compliance, process and resolve rebate claims, prepare managed care financial reports, and track program performance. Provide administrative and financial support while interfacing with contracting, pricing, and membership teams.

Configure, maintain, and validate the Laboratory Information Management System (LIMS) for Fresenius Kabi production sites. Support end-users, perform account administration and troubleshooting, ensure cGMP/GLP compliance during audits, develop SOPs and training, coordinate documentation and site validation, and collaborate with lab and QA teams on LIMS rollouts.

Lead cross-functional project teams to design, scale-up, validate and implement pharmaceutical complex formulation and processing technologies (e.g., emulsions, lyophilization, sterilization). Oversee equipment selection, P&IDs, 3D models, commissioning/qualification, tech transfers to manufacturing, regulatory and safety compliance, process troubleshooting, and continuous improvement to meet production, quality and budget goals.

Lead contracting operations for biosimilars and specialty products, managing rebate/discount processes, contract setup, team leadership, cross-functional coordination, and contract analytics platforms to optimize payer, wholesaler, provider, specialty pharmacy, GPO, and membership contract performance and minimize risk.

Evaluate and lead extractables and leachables (E&L) studies to support FDA submissions. Perform method development, validation, and stability testing in a cGMP lab. Operate and troubleshoot mass spectrometers (GC/MS, HR-LC/MS, LC/MS, ICP/MS), interpret mass spectra, identify unknowns, draft protocols/reports, prepare regulatory summaries, train junior scientists, and manage multiple E&L projects.

Perform chemical characterization of medical device materials (extractables/leachables) using GC/LC-MS and ICP-MS. Develop and validate analytical methods, design and lead studies, write reports, support lab operations and QA in an FDA-regulated GMP/GLP environment, and provide technical review and mentorship to colleagues.

Perform calibration, maintenance, troubleshooting and repair of laboratory analytical instruments; coordinate and review vendor calibrations; maintain calibration records per cGMP/cGLP; create/revise SOPs and preventive maintenance; distribute calibration schedules; ensure secure storage of metrology equipment; assist in selection of test and measurement devices and support quality, safety, and regulatory compliance.