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Process Validation Manager

Would you like to lead a team of highly skilled scientists while being part of projects for global biopharmaceutical companies?  “We have customers from all around the world and handle many different processes. With us, you’ll have a dynamic work life and work with both our customers and all internal departments involved in process development, quality and manufacturing,” explains Kristian Becker, Director, Process Transfer. Contribute to the growth of our Process Transfer department in CopenhagenOur Process Transfer department consists of 3 teams of scientists: Upstream Process Transfer, Downstream Process Transfer and Process Validation. You will head up the Process Validation team of 8 scientists and also be part of the management team for the department.  “Your new colleagues and team members are highly skilled within their field so they will be looking to you as their professional sounding board in a great atmosphere where we help each other to succeed,” says Kristian. Set the strategy for our process validation approachYou will be responsible for leading our process validation activities together with your team, providing coordination of all process validation related activities. This includes preparing and finalizing all documentation associated with process validation according to authority guideline principles.A very important part of your job will be to set the strategy for process validation of several late-stage biopharmaceutical programs. Thus, you will collaborate across the organization with Manufacturing, Quality and Development. Moreover, you will work closely with our customers in each project, facilitating the strategy inclusion into the customer set-up as well as:  

  •  Managing the flow of operations in the team – balancing the work over several projects simultaneously
  •  Communicating clear instructions and feedback to team members and listening to team members' feedback
  • Facilitating and/or providing training for team members
  • Providing innovative solutions to complex problems surrounding the development and manufacturing processes
  • Supporting requests for technical assistance from the rest of the AGC biologics organization globally

Solid experience with process validation “To succeed in this position, you need to not only have great leadership skills but also be able to communicate with customers and colleagues of various cultural backgrounds and obtain buy-in from all key stakeholders,” finishes Kristian. We imagine that you:

  •  Have a degree in science, engineering or a related field (at least MSc or PhD level)
  •  Have several years of biopharmaceutical process validation experience
  • Have some leadership experience and the ability to be the professional sounding board to your team.
  • Are fluent in English
  • Maybe have some knowhow within the Quality by Design methodology

Are we your new colleagues?We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will be taken down. We are therefore looking forward to receiving your application today! 

Want to keep posted about our growth and to learn more about our company?We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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