Process Engineer Launch Plant

Kantoor: 
Sanofi
Referentie: 
1641189
Jobtype: 
Vast contract na interimperiode
Contract type: 
Bediende
Functieomschrijving: 

About the opportunity

Starting from thorough scientific and technical knowledge, you contribute to Technology Transfer activities aiming at introduction of new products and processes at the Sanofi Geel biopharmaceutical manufacturing site. Additionally, you will contribute to improvement initiatives and the monitoring of existing processes at the Sanofi Geel site and within the broader Sanofi network. Your job will consist of manufacturing-scale activities, laboratory-scale activities, or a combination.

About the department

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gas assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

About growing with us

  • Contribute to the introduction of new manufacturing processes for clinical and commercial manufacturing of drug substances for biologics by performing technology transfer from the development laboratory into large-scale GMP manufacturing
  • Provide support to technology transfer by developing strategy for and executing initial process validation activities, including defining process control strategy and performing process performance qualification for the introduction of new products and processes at manufacturing scale
  • Identify and drive process improvements to increase yield or process robustness, and generate a supportive data package supporting implementation at manufacturing scale
  • Provide support to and safeguard commercial production processes by data trending and monitoring, by generating scientific/technical study protocols and reports in support of significant changes and by supporting investigations and process/product impact assessments upon significant deviations in the production process
  • Supporting tech transfer activities and the development of process improvements using small scale cell culture models in the state-of-the-art Geel MSAT labs
  • Support the weekend warrior system of our cell culture lab
Profiel: 

Required Skills & Qualifications

  • PhD or master in Life Sciences, with relevant experience of minimum 3 or 5 years respectively in process development or MSAT-like functions
  • Oral and written fluency in English given the international context
  • You have specific experience in mammalian cell culture processes on lab- and/or manufacturing scale; experience with purification processes is a plus
  • Flexible and willing to support both manufacturing scale operations and small-scale lab studies
  • You like to work in a team and consider yourself a good team player
  • Strong communicator, who is able to connect, go in discussion and find a compromise with people in other departments or sites
  • You have no problem with flexible hours, i.e. occasional work in the evening/weekend
  • You are flexible to adapt to changing priorities and willing to learn at a rapid pace
  • Excellent analytical and problem-solving mindset, and accurate with the necessary eye for detail
  • Familiar with various statistical and data trending techniques, knowledge of or experience with JMP/Statistica/Matlab/Simca is a plus
  • You have a GMP mindset, being familiar with current Good Manufacturing Practices is a plus
  • International mindset – ability to work in a multi-site global organization and open to travel (at least for short term) abroad
Aanbod: 

We offer you:

  • Full-time position in day shift (flexible working hour system)
  • An attractive salary package with meal vouchers (worth €8), a DKV hospitalization insurance,..
  • Evaluations
  • Educations
  • Career opportunities in a growing organization where involvement, integrity, entrepreneurial spirit and collaboration are driving values
  • Proposed start date: ASAP