If you would like to work both hands-on and administrative with a wide variety of different biopharmaceutical production processes and innovative technologies in a great team with many opportunities for development, this position will definitely be something for you.

The position
You will become part of our manufacturing area consisting of five production lines, which produce pre-clinical, clinical and commercial products for a wide variety of customers from around the world. You will be part of a group of highly dedicated technicians and scientists working with various stakeholders such as QA, QC and Development.

As an Operational Scientist within the Upstream team, you will plan and perform cell culture steps in the manufacturing process.

You will be working with these tasks among others:

  • Trouble shoot and support with technical issues
  • Support with overviews of equipment status.
  • Planning, managing and training related tasks
  • Technical improvements within production equipment
  • Administrative tasks such as Change Requests, review MPR, improvements etc.

You will be trained/introduced in:

  • Seed train
  • Set up and use of Cultibags and single use bioreactors 100L / 500L / 2000L and daily samplings.
  • Harvest using Cuno filters and Millistack filters.
  • Perfusion using ATF.
  • Analytical Equipments (Nova BioProfile, Cedex and ViCell)

Your responsibility will include preparation of production rooms and production systems before use, clean up and line change over after use, as well as participate in qualification, maintenance and calibration of upstream process equipment. In addition you will initiate, execute and complete equipment and process related improvements within the team.

Together with the team, you are responsible for the delivery of cell cultures to further processing in the downstream team and for ensuring batch documentation of high quality in close collaboration with QA/QC.

Experience and competencies

The ideal candidate we are looking for has more of the following qualifications:

  • Having +2 years of experience within upstream production and harvest
  • Having in-depth experience and technical skills within equipment such as Single Use Bioreactor processes, ATF, centrifuges, analytical equipment etc.
  • Experience with administrative tasks such as Change Requests, document review etc.
  • Is a scientist or very experienced technician, preferably a process technologist, with hands-on experience from cell cultivation,
  • If you have experience with mammalian cell cultivation this will be an advantage.
  • Has experience from working in a GMP regulated production and following written procedures.
  • Has experience with process optimization.
  • Has an interest in maintenance of equipment.
  • Has excellent collaboration competencies.
  • The ability to speak, read and write English.

As a person, you have a positive mindset, are flexible and proactive. You enjoy taking on new tasks and responsibilities. You thrive in a dynamic environment and can cope with continuous changes.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.

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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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