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Bioprocess Lead - Manufacturing

You are the project lead in a team that manages the production, both USP and DSP, of clinical and commercial products. You work together with clients on determining the needed materials, you write out instructions for the operators, perform risk assessments, and perform data analysis for scale up projects. Does this appeal to you? Apply today so we can discuss the possibilities!

Job Description

You work closely with various clients in project teams to ensure scientifically and technologically correct tech transfer and subsequent production and manufacturing under cGMP regulations. As the Bioprocess Lead in manufacturing, you are mainly responsible for the proper tech transfer from client to the company. You discuss the needed materials and expectations, create the work instructions for operators, perform risk assessments, and do the complete life cycle management. You mainly work hands-off yourself, but you also perform troubleshoots on the floor if something goes wrong.

Responsibilities

  • Collaborate with clients in project teams for tech transfer of production
  • Create SOPs for this process for operators
  • Act as the SME in production for operators
  • Perform risk assesments
  • Ensure life cycle management of the complete processes
  • Troubleshoot and process related support on the floor when needed


Profile

  • At least HBO degree in a relevant field (e.g. biochemistry, biotechnology, bio-pharmaceutical sciences, etc.)
  • At least 5 years of working experience in a GMP-regulated pharmaceutical or bioprocess environment
  • Experience with technology transfer and process validation in a manufacturing environment
  • Experience with process validation, trending, and data analysis for scale-up
  • Strong communicative and people skills
  • Dutch language skills are a pre


Practical information and Benefits

  • Salary indication: €4200 - €5000, depending on experience
  • Direct contract with our client, long term position
  • Excellent secondary benefits
  • Fulltime position, 32h is discussable
  • Location: Amsterdam

Vacancy number: 21749

IMPORTANT NOTE: Please do not apply if you do not have a working permit to live and work in the Netherlands. Your application will not be processed.