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USP Specialist – Cell & Viral Drug substance


  Wavre,   Competitive

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  Technical Operations    Contract

Vacancy Details

My client, a leading pharmaceutical manufacturing organisation are looking for an USP Scientist – Cell and Viral drub substance  for their site in Wavre.

Title: USP scientist   

Salary: Competitive

Location: Wavre

 

The USP Scientist is a biopharma industry-experienced development scientist specialized in the upstream field joining a team of experts focusing on Drug Substance process development for new vaccine candidates from Phase I up to commercial launch, as well as on Life Cycle activities for process improvements in the commercial vaccine portfolio.

 

Responsibilities

  • You will be expected to autonomously support the USP leader of several drug substance development projects that run in parallel as required
  • You will be expected to have project management skills, design experiments, plan experimental protocols, lead horizontally a team of technicians to execute them, having presence in the lab to ensure best practices, compliance with documentation practices and EHS standards
  • You will be expected to follow the Quality by Design approach to process development, which means potentially participating in technical risk assessment sessions, perform experimental plans or write technical documentation to meet QbD deliverables
  • You will work very closely with the USP leader, DSP leader and Scaleup team from the development stages to ensure knowledge sharing, transparent communication of plans and status and a smooth transition throughout the scales required at the different project phases,
  • You will closely collaborate with the InProcess Analytical organization to implement IPA testings as fit for upstream processes.
  • You will be expected to write and review project reports including process history files, process development reports, etc

 

Basic qualifications

  • PhD in bioengineering, biochemistry, biotechnology, chemistry or equivalent or a
  • Master in bioengineering, biochemistry, biotechnology, chemistry or equivalent.
  • A minimum of 2 years’ experience in Upstream Drug Substance Development and/or Manufacturing (Product and Process Expert) in biopharma/ biotech industry

 

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call +49 6995179969 for a confidential discussion about potential opportunities.

Joe.Lane

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