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

1. Create excel spreadsheet to support Nitrosamine Risk Assessment for all US products 2.Data collection from various sources, such as SAP, Documentum/eDMS, Regulatory database, external manufacturer documentation 3.Needs to collaborate with various functions within the organization Compensation $20.50/hr $24.50/hr depending on level of education Responsibilities Student

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

The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively

The ISO Systems & Sustainability Manager is responsible for the management and maintenance of all local requirements under the 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 with the current ISO Standards, as we

The Training Specialist is responsible for the successful design, development and implementation of training at the Plant Level. Work closely with the Training Manager in developing and implementing training plans. Design needs/tasks analysis, develops training materials, implements project plans for appropriate locations, schedules training sessions, writes training modu

We currently have an opportunity for a summer 2024 intern to join the Engineering team at our Grand Island, NY facility. Responsibilities Interact with Production and Engineering personnel to identify areas of improvement Support engineering team with project execution Help with engineering and manufacturing documentation Provide engineering support related to capital pro

Designs, develops, implements and supports all aspects of electrical control systems, equipment, and machinery related to site utilities, production equipment, and facilities. Is a technical resource to the Engineering, Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capa

We currently have an opportunity for a Summer 2024 Intern to join our Manufacturing Engineering team at our Grand Island, NY facility. Responsibilities Interact with personnel on all levels in Production. Collect data on existing challenges, perform analysis, and determine best possible course of action to address them. Look for ways to standardize tasks in order to reduc

We currently have an opportunity for a Summer 2024 Manufacturing Engineering Intern to join the Team at our Grand Island, NY facility. Responsibilities Interact with personnel on all levels in Production. Collect data on existing challenges, perform analysis, and determine best possible course of action to address them. Look for ways to standardize tasks in order to reduc

Responsible for assisting the Cleaning Validation Leader and/ or Supervisor in the coordination of the overall Cleaning Validation Policy from a site and corporate perspective to insure compliance. Performs cleaning validation chemical and sampling/testing as required. This position reports directly to the Cleaning Validation Supervisor or Manager of Product Transfer and

The Plasma Services Consultant is responsible for providing technical and operator l product and sales support for customer organizations within an assigned territory in US. Act as key customer liaison and consultant managing both customer and company needs. Assist in process and operational improvements within a customer center and ensures that customers are properly tra