The Production Group Leader will be responsible for all daily operations of functional department without direct supervision on the shift. Responsible for training all employees on that shift, allocating resources, scheduling shift activity and insuring cGMP compliance in operation. This cross functional role is also responsible for assembling, operating, and monitoring s

Chargeback Analyst is responsible for analyzing, researching, resolving, and trending chargeback discrepancies resulting in issuance of appropriate credits within Wholesaler / Distributor contractual terms. Chargeback Analyst is responsible for developing and maintaining strong collaborative relationships with Wholesaler / Distributor partners. Chargeback Analyst is respo

Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individ

Responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Independently executes protocols, verifications, method transfers in support of senior level personnel. Directs and provides guidance to associate scientists. Responsibilities Be able to articulate work related iss

A Scientist II in Quality Control displays an advanced knowledge in chromatographic techniques and instrumentation, and guides others in troubleshooting instrumentation and routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. Responsibilities Principal Activities and Responsibilities Be able to articula

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities Visually inspec

The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates

Responsible for the accurate weighing, checking and mixing of specific chemical compounds for product formulations; the calibrating and monitoring of a variety of mixing machinery and the accurate documenting and maintaining of production logbooks and records. They're also required to follow all departmental and company SOP's and maintain accurate and timely record keepin

The ISO Systems and Sustainability Manager is responsible for the management and maintenance of all the local requirements under ISO 14001 Environmental Management System (EMS), ISO 45001 Occupational Health and Safety Management System (OHSMS), and ISO 50001 Energy Management System (EnMS) for the Plant (Production Unit) in accordance to the current ISO Standards, as wel

The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and execution of clinical dev

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities We offer state

An Associate Scientist is responsible for performing entry level chemical testing to support raw material, in process, stability, and finished products as required for Quality Control. Effectively communicates work and results both orally and in writing. Responsibilities Able to articulate work related issues clearly and effectively to management and peers Perform accurat

The Project Manager is responsible for the effective management (organization, financial/project planning, execution, control and evaluation) of all aspects of assigned projects. The Project Manager will effectively collaborate with project governance boards, communicate project status to management and provide resolution of project issues. This position requires a dynami

The Sr. Manager, FDA Compliance (Global Remediation Officer) assures that all plants and I&D Centers having activities with US FDA are in compliance with US FDA regulations, including but not limited to, cGMPs, cGLPs, & cGCPs. This includes foreign facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and pr

The Sr. Manager, Manufacturing Quality US Supply Sites will assure that all activities associated with manufacturing of products within the portfolio of all sites manufacturing for distribution in the US comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ). The oversight will also extend to the assurance