Senior Tech Transfer Specialist

 Jobomas DE
 Deutschland, North Rhine-Westphalia, Germany
 vor 3 Tage, 18 Stunden
BioTalent have partnered with WuXi Biologics, a global CRDMO leveraging its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. They have global clients bringing in new products to their filling-finish facility based in Germany, which is why they need you! WuXi Biologics are looking to hire a Senior Tech Transfer Specialist to join them on a permanent basis in Leverkusen, DE. As a Tech Transfer Specialist, you will be leading sophisticated Drug Product technology transfers, commercial scale-up, process validation, and lifecycle management aspects of biological drug products. Responsibilities Lead Drug Product Technology Transfer and scale-up projects as part of a Drug Product Tech Transfer team, to achieve targets in a timely fashion and to agreed quality standards. Provide Technical oversight and resolution of any drug product related technical issues on commercial products. Deliver indirect scientific or technical mentorship and leadership to Engineers and Technicians to enable them to optimally meet their project objectives. Provide technical expertise in process equipment and qualifications in start-up of new manufacturing sites. Manage continuous improvement projects, design changes and lifecycle of commercial drug products in working with other relevant Global Tech Ops teams. Collaborate with Biological Process Development to scaleup and transfer new drug product processes. Ensure that work is performed in accordance with appropriate quality and compliance standards. Represent the technical operations function on drug product technology topics in cross-functional development teams, ensuring the provision of appropriate data (technical, resource & budgetary). Maintain an awareness of the status of core technical challenges and opportunities in area of expertise for the current combination product portfolio. Create and maintain control strategies, design and risk management documentation. Qualifications BS in Engineering or relevant scientific field. 5+ years of industry experience Technical experience in drug product fill/finish activities. Experience of working with biological products (biologics/vaccine). Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment. A detailed understanding of the principles and concepts in relation to parental/drug product technology development and lifecycle management. Project management, innovation skills, and a thorough understanding of critical unit operations involved in drug product manufacturing. Good scope of knowledge of the overall drug development process from discovery through to launch. Advantageous to have experience preparing regulatory documentation. English writing and oral fluency. German speaking is advantageous. Join WuXi Biologics and help deliver life changing medicines! Be among employees who continue to make WuXi an innovative company that stands firmly among the leaders. Please send your CV to 'james.bayliss@biotalent.com' if you would like to learn more!

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