Cell Line & Upstream Process Development Engineer

About the job

As a Process Development Engineer Cell Line Development & Upstream Process Development you will play a key role in the development of robust scalable mammalian cell lines and upstream processes to support biologics manufacturing. You will work in a multidisciplinary team at the interface of research process development and GMP manufacturing contributing directly to the successful transfer of processes toward clinical and commercial production.

Your expertise will help establish and optimize cell culture processes while ensuring scientific rigor reproducibility and readiness for future GMP implementation.

Responsibilities

Cell Line Development

• Design execute and optimize strategies for mammalian cell line generation screening and selection.
  
• Perform clone evaluation based on productivity stability growth and product quality attributes.
  
• Maintain detailed experimental documentation and ensure data integrity.
  
• Support scale-down models representative of GMP manufacturing processes.
  

Upstream Process Development

• Develop and optimize upstream processes in shake flasks and bioreactors.
  
• Evaluate media feeds and process parameters to improve productivity and robustness.
  
• Analyze process data and translate results into scalable and transferable process knowledge.
  
• Support technology transfer of upstream processes to GMP manufacturing or external partners.
  
• Collaborate closely with downstream process development analytical development quality and manufacturing teams.
  

• Contribute to development reports process descriptions and technical documentation.
  
• Support risk assessments process characterization and comparability studies.
  
• Ensure compliance with data integrity principles and where applicable GMP expectations.
  

Vereisten

• A Masters or PhD degree in Biotechnology Biochemistry Cell Biology Bioprocess Engineering or a related field.
  
• Proven experience in cell line development and/or upstream process development for mammalian cell culture.
  
• Hands-on experience with cell culture techniques and bioreactor systems.
  
• Strong scientific mindset with excellent data analysis and problem-solving skills.
  
• Experience working in a regulated (GMP or GMP-adjacent) environment is a strong asset.
  
• Well-organized detail-oriented and capable of managing multiple development activities in parallel.
  
• A proactive collaborative and results-driven attitude.
  
• Strong communication skills both written and verbal.
  
• Flexibility and adaptability within a dynamic fast-growing environment.
  
• A start-up mentality with a willingness to take ownership and drive innovation.