Head, Purification Development

Head, Purification Development

Sanofi

Vitry-sur-Seine, France

Purpose of the job:

The Global Purification Process Development group within Sanofi operates with the mission to develop robust, scalable and innovative purification processes for Sanofi’s very diverse early and late-stage biologics pipeline. In this position, we are looking for a candidate with excellent scientific, communication and leadership skills to lead a group of purification scientists supporting this mission. The candidate will be expected to drive towards establishing state-of-the-art purification development capabilities within QbD paradigm with experience in developing control strategies (risk assessment, process characterization, PPQ) towards BLA submissions.

Responsibilities:

  • Leading a skilled group of purification scientists for purification process and technology development in Vitry within a global development organization;
  • Build strong interface to global partner groups in Germany and the U.S. as well as collaborators in cell culture development, analytics, formulation and Industrial Affairs groups;
  • Develop downstream processes supporting pre-clinic to launch applying principles and techniques such as QbD, DoE, OFAT, PAT and FMEA-based risk analysis;
  • Evaluate and implement state-of-the-art technologies for the purification of antibodies and related molecules including nanobodies, multi-specifics, Fc-fusion proteins;
  • Scale-up of purification processes to clinical and commercial manufacturing sites and design and execution of process characterization and process validation studies (PPQs);
  • Design and implement concepts for i.e. control strategy, validation strategy, developability, manufacturability, continuous processing, disposable technology, virus validation and digitalization.

Qualifications:

  • PhD in natural sciences (chemistry, biochemistry, biology, biotechnology or similar) or engineering (chemical engineering);
  • Excellent experience in the development of chromatography- and filtration-based purification technologies and processes as well as the analytics of biologics (> 5 years);
  • Experience in the manufacturing of biologics, especially in the early and late-stage development phase with emphasis on regulatory compliance strategies, GMP requirements and dossier submission to health authorities;
  • Experience in the digitalization of systems and lab workflows or the set-up of LIMS and documentation principles beneficial;
  • Analytical mindset plus independent and well documented way of working;
  • Experience in leading international teams;
  • Independent way of working;
  • Excellent oral and written communication skills in English and French; German is beneficial;
  • Excellent team leadership and communication abilities (also in international and interdisciplinary project teams).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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