1. Our position

Analytical Development Specialist

• Location: Geel
• Remote work: sporadically, up to 10% travel
• Job type: Permanent

2. About the job

Our Team:

Manufacturing Science, Analytics and Technology (MSAT) continuously explores improvements at the interface between CMC development and commercial production. MSAT’s primary functions are to lead technology transfer, develop new products and methods & support licensure, provide commercial manufacturing technical support and development improved manufacturing processes and methods.

The analytical function in the MSAT organization is the owner of the analytical methods within the Sanofi biologics manufacturing network. We develop, implement, and validate efficient analytical platform technology for analytical life cycle management (LCM). For MSAT and global projects, we deliver innovative and cost-efficient second-generation methods, thoroughly characterize the product, and provide analytical support for process development and LCM using complex and state-of-the-art technology.

Main responsibilities:

• End- to-end method responsibility, starting with method development up to method validation and transfer into a quality control organization
• Subject-Matter expert on analytical technology with extensive knowledge of protein interaction methodologies (e.g., SPR, BLI and ELISA) and biochemical/enzymatic assays (e.g., enzyme kinetics, apTT, chromogenic activity)
• Identify opportunities to deploy PAT technology and automation of analytical methods
• Program assay workflows on automated liquid handling systems such as Hamilton Vantage and Tecan EVO and act as a contact point for automation within the Geel MSAT team
• Follow-up on automation initiatives within the Sanofi biologics manufacturing network and collaborate with other automation experts within the network to align automated workflows.
• Identification of improvements for existing methods to introduce new technology, increase method robustness and reduce release cycle time
• Investigational support for product and process, generation of scientific/technical study protocols and report
• Support analytical activities for product characterization, transfer and process improvements for existing commercial products

3. About you

• Experience:
  • You have at least 3 years of relevant experience in method development, validation, and investigation testing/support in an analytical function
  • You have a good understanding of GMP and the manufacturing & testing of biologics
  • You have significant hands-on experience in automation projects and robotics in the field of analytics. This includes designing, implementing and qualifying analytical methods on automated systems

• Technical skills:
  • You have specific experience in analytics e.g. protein interaction assays, bioassays, spectrometric assays, molecular technology, ELISA
  • Experience with growing cells in bioreactors or purification processes is a plus
  • You are experienced in protein characterization
  • Proficiency in programming languages (e.g., Python, VBA), knowledge of control systems and robotics and high level of familiarity with Tecan EVO and Hamilton vantage automation software and tools are essential
  • You are flexible and willing to support small scale studies, quality investigations and MSAT driven projects both in the lab and as part of a cross-function teams
  • You have a problem-solving mindset
  • You are a strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites
  • You are familiar with statistical tools
  • You are a team player

• Education:
  • You have a PhD or Master in Life Sciences or equivalent through relevant experience

• Languages:
  • Dutch
  • English, fluent in writing and speaking