SR TECHNOLOGY TRANSFER LEADER

Job Summary POSITION SUMMARY The Sr. Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and global I&D teams. Responsible for project managing the transfer and implementation of projects and technology from development groups to the plant manufacturing site. Responsible for designing manufacturing procedures of varying degrees of difficulty for new or modified products. Responsible for the oversight of the manufacture of development, stability, product validation batches, and cleaning validation/verification studies, as needed. Responsible for the above technology transfer activities related to projects with outside development labs and contract manufacturing customers. Responsible for assisting with and/or coordinating the training of newly hired Technology Transfer Leaders as well as providing direction and support to other staff members within the group. Responsible for the coordination and tracking of routine departmental tasks. Also responsible for providing technical support to manufacturing operations as assigned by management. The focus of the Senior Technology Transfer Leader is on technical aspects of the department and usually does not have direct report, however this position is expected to function as a coordinator of specific routine departmental tasks and assist in the training new employees within the Technology Transfer department. The Senior Technology Transfer Leader will also serve as a source of direction and support to other staff members within the group. The Senior Technology Transfer Leader must also have outstanding verbal and written communication skills because this position interacts directly with multiple departments at the site, regional and global levels. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Communicates plant issues and tasks with the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches. Project manages all projects related to new products, product modernization and all product transfers. Communicates as necessary with the various plant departments, other support departments, project team members, and own department. Is expected to be responsible for those new projects with a high level of difficulty. Authors master batch records and protocols for the manufacture of development, stability, and validation batches. Translates development findings into manufacturing processes. Identifies and implements best practices and procedures designed to provide robust manufacturing processes. Provides information and documentation needed for regulatory submissions or responses as required. Plant liaison for manufacturing processes to other departments within the site, other business units within the company, and marketing units. Serves as the plant point of contact for channeling all manufacturing related questions and issues for resolution. Technically assesses changes in manufacturing through appropriate review of documentation and testing results. Reports changes through risk assessments. Provides technical support for Investigations, Action Plans and Material Change Requests, etc. as required. Generate innovative solutions to solving difficult problems that may impact multiple disciplines. Advises management regarding appropriate action. Develops and executes necessary investigative studies and validation protocols as required Reviews as required various technology transfer documentation with regulatory and other appropriate groups Identifies project requirements and facilitates requirements with outside customers and vendors, as required. Project manages routine departmental assignments such as project time tracking, APQRs schedules, Product Modernization and Continue Process Validation monitoring as required. Assist in the training of new employees to the Technology Transfer department Provides first level of support and direction to departmental staff members as required Technical reviewer for tables and protocols and final reports (as assigned by manager). Tracks and coordinates routine departmental tasks. Actively participates in leadership training. Serve as a designee in the absence of the Technology Transfer Manager REQUIREMENTS Minimum of a Bachelor's degree in science, engineering, or equivalent experience Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities 5-7 years experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise Completed and passed requirements for greenbelt. Knowledge of parenteral product development, manufacturing processes, validation, cGMP's and FDA regulations for the Pharmaceutical Industry. Work under minimal supervision on all projects with various level of difficulty. Typical work hours are the standard first shift, however execution of protocols will often require work on nights and weekends to meet the production schedule. Flexibility with schedule is required. Schedule based on a 40 hour work week with the number of hours per day flexible to support protocol execution and production schedule. 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 match, 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. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 35,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr