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职位信息

职位信息
Tech transfer senior specialist
Dec. 03, 2020
Tech transfer senior specialist
中国
Leverkusen
工作职责:
  • 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
  • Work collaboratively to build technical communities
任职能力:
  • BS in Engineering or relevant scientific field
  • 5+ years of industry experience
  • Technical experience in drug product fill/finish essential
  • 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 parenteral/ drug product technology development and lifecycle management
  • Project management, innovation skills, and a thorough understanding of critical unit operations involved in drug product manufacturing
  • An in-depth knowledge of relevant compliance systems as appropriate to own function
  • Good scope of knowledge of the overall drug development process from discovery through to launch
  • Have experience of technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects
  • Evidence of strong communication skills and of building good relationships with cross functional team members and customers


  • 其他要求:

 

Are you interested in becoming part of this culture and actively shaping the future of WuXi Biologics?

 

Then we look forward to receiving your application documents (CV in German and English), stating your salary expectations and the earliest possible starting date.

Please send your application by e-mail to: Recruiting_Germany@wuxibiologics.com

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WuXi Biologics Germany GmbH | CHEMPARK Wuppertal | Herr Melanie Cangalovic | Friedrich -Ebert-Stra?e | 42117 Wuppertal | https://www.wuxibiologics.com