Fresenius Kabi

• Define and implement a comprehensive R&D performance framework • Establish clear tracking of deliverables, milestones, timelines, cost, and quality indicators • Monitor portfolio execution performance and identify risks and mitigation actions • Lead structured diagnostics of R&D processes and design end-to-end process re-engineering initiatives • Drive continuous improvement initiatives across R&D using Lean Six Sigma and other operational excellence methodologies • Design, harmonize, and optimize end-to-end R&D processes across CMC, Clinical, Regulatory, and other functions • Provide input and recommendations on R&D operating models and governance structures • Drive change management initiatives linked to transformation programs

• Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas. • Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services. • Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations. • Lead cross-functional teams and drive oversight of CRO’s and vendor management. • Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.) • Responsible for inspection readiness. • Accountable for CAPAS related to clinical programs within the field of Clinical Operations. • Accountable and responsible for the financial planning, budget, accruals, forecasts contribution. • Preparing clinical program updates and/or contribution to them as needed.

Title: Associate Research Scientist (Cell & Gene Therapy) Location: Lake Zurich, IL Full time Job Description: Job Summary The Associate Research Scientist plans, executes and analyzes experiments in cell and gene therapy manufacturing. Collaborates with both internal and external stakeholders in advancing pipeline. Salary Range: Job Posting Range: $95,000 - $105,000 • Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level) • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role: Onsite 3 days per week Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities - Design, execute, and analyze complex experiments related to cell and gene therapy manufacturing processes. - Develop and optimize cell culture and purification processes for clinical and commercial manufacturing. - Collaborate effectively with cross-functional teams, including R&D, engineering, product management, and quality control, to ensure project success. - Maintain detailed experimental records and generate comprehensive reports to communicate findings. - Proactively identify and troubleshoot technical challenges, implementing innovative solutions to overcome obstacles. - Stay abreast of the latest advancements in cell and gene therapy manufacturing technologies and industry trends. - Operates within Fresenius Kabi Good Documentation and Good Laboratory Practices This job position within the Business Unit – Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS). Requirements The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Ph.D. with 1+ years of relevant experience, M.S. degree with 2+ years of relevant experience, or B.S. degree in Engineering (Biomedical, Biochemical, Mechanical, Systems, or similar) or Biology with 3+ years of relevant experience. • Experience in cell culture, aseptic technique, and cellular analysis methods (such as flow cytometry, microscopy, ELISA, etc.). • Proven track record of written publications and/or oral presentations. • Strong analytical skills. • Demonstrated leadership and project management abilities. • Self-motivated and capable of working independently. • Excellent verbal and written communication skills. • Willingness to travel up to 10%. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Deliver exceptional customer service by managing inquiries, resolving issues, processing returns, and collaborating with cross-functional teams to ensure customer satisfaction and operational excellence in a fast-paced environment.

Collaborate with cross-functional teams to develop and implement marketing strategies, analyze customer insights for tactical execution, and manage projects within budget while ensuring compliance with regulatory standards.

Title: Project Manager, Contract Marketing Location: Lake Zurich, IL Job Description: The Project Manager is responsible for leading the planning, execution, and delivery of contract marketing initiatives supporting the pharmaceutical business. This role manages integrated project plans, timelines, and milestones to ensure projects are executed accurately, efficiently, and in compliance with established processes and business requirements. Serving as a key operational lead, the Project Manager coordinates cross-functional stakeholders across Sales, Pricing, Finance, Legal, and Commercial Operations to drive alignment, accountability, and successful project execution. The role proactively identifies and mitigates risks, manages dependencies and issue resolution, and provides ongoing project monitoring and communication to leadership and stakeholders. Through effective coordination and execution, the Project Manager supports timely decision-making and the achievement of commercial objectives. This is a hybrid position, and the selected candidate will be required to work onsite in the Lake Zurich, Illinois office 3 days a week. Salary Range: $100,000 - $125,000 per year Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Responsibilities - Lead the planning, execution, and delivery of contract marketing initiatives supporting the pharmaceutical business, ensuring projects are completed accurately, efficiently, and in compliance with established processes and business requirements. - Manage integrated project plans, timelines, milestones, deliverables, and dependencies to support successful execution and achievement of commercial objectives. - Communicate project status, risks, dependencies, financial impacts, and key updates to leadership and cross-functional stakeholders to support informed decision-making. - Coordinate and collaborate with cross-functional teams, including Sales, Pricing, Finance, Legal, and Commercial Operations, to drive alignment, accountability, and KPI achievement. - Proactively identify, assess, and mitigate project risks and issues while facilitating timely resolution and escalation when appropriate. - Develop, maintain, and distribute project documentation, reporting, planning materials, and meeting updates to ensure effective project governance and communication. - Provide day-to-day project coordination and guidance to team members in partnership with functional leaders to support successful execution of project objectives. - Contribute project insights, operational recommendations, and execution updates to prioritization, resource planning, and portfolio governance discussions. - Monitor project progress and performance metrics to ensure timely delivery, operational effectiveness, and continuous process improvement. - Conduct lessons learned and project close-out sessions to obtain information that can be used to improve future projects. - Attend local, national, and global meetings as needed. - Completes all training requirements, including all department-specific, compliance training, etc. - Participates in any and all reasonable work activities as assigned by management. - All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Requirements - Bachelor’s degree required. - Minimum of 5 years of related experience, preferably within project management, management consulting, transformation programs, or a B2B environment. - Proven project management experience required; PMP certification preferred. - Strong organizational, project management, and planning skills with the ability to manage multiple complex projects and competing priorities simultaneously. - Demonstrated ability to identify risks, solve problems proactively, and drive projects to successful completion within established timelines. - Strong analytical and critical thinking skills with exceptional attention to detail and accuracy. - Excellent verbal, written, presentation, and interpersonal communication skills with the ability to effectively collaborate across cross-functional teams and leadership levels. - Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook), SharePoint, and ERP/database systems such as SAP. - Experience working within a regulated industry required; healthcare or pharmaceutical industry experience preferred. - Ability to work independently, exercise sound judgment, and adapt effectively in a fast-paced, evolving environment. - Ability to collaborate effectively with all employees and external business contacts while conveying a positive, service-oriented attitude. - Highest level of integrity and good judgment, with the ability to effectively deal with highly sensitive, confidential information. - Ability to work flexible hours and weekends to meet business/customer needs. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Title : Manager, Commercial Enablement Location: Lake Zurich, IL Job Description: Job Summary The Manager, Commercial Enablement (Commercial Excellence) plays a critical role in driving digital transformation and process optimization across Fresenius Kabi’s U.S. commercial business. This position focuses on implementing technology solutions, enhancing CRM and lead management processes, and enabling omnichannel strategies that support sales and marketing effectiveness. Partnering with cross-functional teams, the manager helps develop governance frameworks, champions change management and delivers actionable insights through data analytics. The role requires strong leadership in digital strategy alignment, project management, and stakeholder collaboration to ensure scalable, compliant, and innovative solutions that advance Commercial Excellence objectives. This is a hybrid position, and the selected candidate will be required to work onsite in the Lake Zurich, Illinois office 3 days a week. Salary Range: $120,000 - $135,000 per year Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Responsibilities - Execute commercial enablement initiatives aligned with Commercial Excellence objectives, focusing on process optimization, technology adoption, and digital marketing tactics. - Partner with cross-functional teams (Sales, Marketing, Operations, IT, Data Analytics) to implement digital tools and workflows that enhance commercial processes. - Drive process improvement projects to streamline CRM utilization, and digital marketing initiatives including omnichannel orchestration. - Develop governance frameworks for platforms ensuring consistency, scalability, and compliance aligning digital initiatives with broader Commercial Excellence strategies. - Champion change management and training programs to drive adoption of commercial processes, digital tools and best practices. - Execute proof-of-concept initiatives to test new technologies before full-scale deployment. - Develop structured onboarding and training programs for new tools and processes and create feedback loops to refine workflows for continuous improvement. - Evaluate emerging digital tools and technologies for potential integration into the marketing technology stack, ensuring alignment with Commercial Excellence objectives and scalability across the organization. - Manage large-scale projects and vendor relationships to deliver successful digital initiatives and program evaluations. - Analyze commercial performance metrics, aggregate data and provide actionable insights for sales & marketing enablement and customer segmentation. - Partner with Sales and Marketing teams to refine and standardize the lead qualification process, ensuring alignment that leads to sales adoption and follow through. - Support Marketing teams with campaign optimization, KPI development, and guidance on digital trends and best practices. - Completes all training requirements, including all department-specific, compliance training, etc. - Participates in any and all reasonable work activities as assigned by management. - All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Requirements - Bachelor’s degree (focus in Marketing, Communication, Advertising, or digital applications preferred) - 8+ years related experience in digital marketing analytics with a focus on campaign management. - Experience working in a highly regulated industry (i.e., pharmaceuticals, finance, insurance, banking) is preferred. - Experience collaborating with digital marketing to establish user requirements. - Strong analytical skills in Digital Marketing, Ecommerce & digital optimization. - Solid interpersonal and effective communication skills (verbal and written) with internal stakeholders and outside agencies, partners, and vendors. - Proficient with Microsoft Office (Excel, Word, PowerPoint, Outlook), and other database/ERP concepts (i.e., SAP, Salesforce.com); advance experience in Google Platforms and Adobe Experience Manager. - Able to manage and prioritize multiple complex projects with demonstrated time management skills. - Excellent organizational skills accompanied with strong project management, and planning skills. - Must possess strong analytical skills with attention to detail and accuracy. - Demonstrated ability to prioritize and execute tasks in a fast-paced dynamic environment. - Ability to collaborate effectively with all employees and external business contacts while conveying a positive, service-oriented attitude. - Highest level of integrity and good judgment, with the ability to effectively deal with highly sensitive, confidential information. - Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment. - Ability to work flexible hours and weekends to meet business/customer needs. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Title: Regulatory Specialist Location: Lake Zurich United States Job Description: time type Full time job requisition id R-01021946 Job Summary The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no direct reports. Rate of Pay: $100,706.01 to $110,422.12 USD Annual Responsibilities Duties: - Represent Regulatory Affairs Dept. on project teams and provide regulatory guidance to clearly and convincingly communicate complex issues as well as share expert knowledge of complex issues (15%). - Review technical documents for cGMP and regulatory compliance (10%). - Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%). - Prepare and file high-quality submissions to regulatory authorities including A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates (25%). Communicate importance of quality assurance (5%). - Develop regulatory strategy for difficult issues which could significantly impact project timelines and costs (5%). - Provide regulatory decisions with regard to acceptability of submission documents and decisions (10%). - File all applications in accordance with predetermined timelines (15%). - Share with others best practices for planning, organization and time management (5%). - Function as a Special Projects Manager to support COO office on priorities, including project management, communications material development (5%). Work from office 3 days per week and 2 days per week remote. Requirements: - Must have a Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology or related field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area supporting pharmaceutical regulatory affairs. - Must also possess the following: demonstrated expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA; demonstrated expertise successfully completing supplements and/or amendments approved by the FDA; and, demonstrated expertise understanding CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary Highly experienced engineering position, under minimal or no direct supervision guides the designing, building and maintaining software used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve problems of high complexity. May assist and mentor experienced engineers Salary Range: $150,000-$155,000 • Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities This engineer guides the conceptualization of new methodologies while Identifying improvements for processes and best practices of software development. Generates innovative solutions to complex problems using multiple disciplines and technical principles. Advise senior management regarding appropriate action. Analyzes, plans, designs, executes, and documents high complex software applications and/or processes within established medical product design controls. Designs and develops software adhering to product requirements, definitions and/or program goals. Applies standard techniques in solving complex problems, performing root cause and failure analysis. Requirements • Bachelor’s degree in Engineering is required, Information Technology or related field is preferred. • 8+ years of experience in software engineering, troubleshooting, and solving problems. • Experience in the software development life-cycle methodology and software product implementation. Experience of medical device development processes and FDA regulations a plus. • Demonstrated experience in designing and implementing performant system software solutions using a variety of technologies. • Advanced experience in using Object Oriented design patterns in multi-tiered and multi-layered architectures. • Advanced Experience with C#, .Net Framework / .Net Core, Entity Framework, SQL Server, Windows Services and Web Services is required. • Experience with HTTP, SOAP, and REST protocols. Experience in internet networking design architecture for real-time communications is a plus. • Experience with cloud services such as Azure, AWS, GCP is desired. • Experience with microservices and Kubernetes is desired. • Experience working with virtual and cloud environments is required. Experience with VMWare is desired. • Experience with various types of automated testing such as Unit, Integration, System, Performance, Load/Stress, Regression is desired. • Ability to diagnose and solve complex problems involving multiple technologies. • Knowledgeable in source control management and configuration. Experience with Git/Bitbucket desired. • Ability to work as a collaborative team member. • Advanced in problem solving, analytical, troubleshooting, and debugging skills. • Strong attention to details, natural inclination to be methodical. • Excellent in written and verbal communication skills Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution , and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary The Senior Engineer, Reliability can play a key contributor role in our Hardware Development Team and reliability programs. This role plans and contributes to the reliability program activities to meet the reliability, safety, quality, and business goals. The Senior Engineer, Reliability, work under moderate supervision. Participates in designing, building and maintaining of processes and documentation to test, report and improve the reliability of medical device hardware and software. Salary Range: $85,000 - $95,000 • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role, 3 days per week in Warrendale, PA Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities Plans, designs, executes, documents, and analyzes a regimen of tests to predict the reliability of new products and product changes. Operates within defined processes and procedures consistent with a regulated environment. Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors. Effectively operates as an individual contributor and a member of the large team. Exercises judgment within defined procedures and practices to determine appropriate action. Participates in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects. Maintains reliability test equipment including the execution of regular maintenance activities. Accurate recording of test results and defects in Excel, Jira, or other test databases. Assists in root cause analysis of Field Returns and Reliability Test failures. Develops and maintains detailed troubleshooting documentation, for both internal and external customers. Assists in documentation, tracking, and analysis of field failure data. Develops and executes written test protocols designed to evaluate and demonstrate product reliability including but not limited to QALT (Quantitative Accelerated Life Testing) and Reliability Life Testing. Develops, fabricates, and qualifies reliability test fixtures. Design in collaboration to the Hardware and Sustaining teams and develop processes, tools or fixtures for testing products. Organizes test records to ensure that records are indexed, archived, and can be retrieved. Evaluates results relative to program goals. Applies standard techniques to solving difficult problems. Applies functional understanding of reliability theories and practices to daily activities. Display full understanding and knowledge of regulations to apply guidance and standards on reliability activities and work products; prepare documentation for compliance with standard operating procedures. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements with company contribution , and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.