Technology Transfer Specialist (m/f/d)

Description du poste

Technology Transfer Specialist (m/f/d) The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch. We are looking for a Technology Transfer Specialist (m/f/d) to start as soon as possible in full-time. The Technology Transfer Specialist (m/f/d) will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy. The Technology Transfer Specialist (m/f/d) role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working Activities Within Role: Bring energy, knowledge, innovation to carry out the following. Responsibilities and activities can be tailored to successful candidate availability and career plan and would primarily entail, but are not limited to: • Support of developing and shaping tech transfer program. • Collaborate with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, deviation, investigation, change controls, batch records, sampling plans, Bills of Material. • Maintain and feed information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV. • Manage new program introduction schedule to ensure tasks are executed on schedule and right-first time. • Contribute/support in various teams as Tech Transfer representative. • Manages small projects with moderate resource requirements, risk and/or complexity. • Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes. • Supports design and implementation of best practices in tech transfer • Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer. • Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned. • Writing, maintaining of BOM's (Bill of material) and EBR’s (Paper), gBMR (MES) and SOPs/WI’s. • Demonstrate excellent troubleshooting and problem-solving skills, and e ability to collaborate and work effectively within global and interdisciplinary teams. • Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives. • Support to aggregate process related knowledge and centralize for knowledge management. • Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals • Ensure the highest Quality, Compliance and Safety standards. Required Education, Experience and Skills: • A degree qualification in a relevant field (Science/Technical) • Minimum of 5 years of work experience in the relevant industry • Familiarity with Unit Operations for mAb manufacturing • Project management basic knowledge • Competent in issuing and transcribing information into documents required for manufacturing such as BOM, Batch Sheets and DeltaV • Competency in the use of automated/digital systems such as DeltaV, MES, eVal, SAP COMET • Has managed a small project with a cross-functional group • Working knowledge of cGMP regulations • Understanding of the general principles of New Product Introduction (Tech Transfer) Preferred Experience and Skills: • Oral / written communication skills in English (B1) would be must and German would be desirable • Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. • Competent in analyzing complex situations and showing practical problem-solving capabilities • Familiarity with risk assessment processes • Competent in analyzing complex situations and showing practical problem-solving capabilities • Familiarity with the use of Automation systems in a manufacturing Process. • Ability to work effectively as part of a team and independently. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients. Our Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence». We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.