Process Engineer/Analytical Dev Sp II

le contenu du travail

• Our position
• Manufacturing Science, Analytical and Technology - MSAT Process Engineer/Scientist Cell Culture
• Location: GEEL
• Job type: Permanent
• About the job
  
  

Our Team:

The Manufacturing Science and Analytical Technology (MSAT) mission is to enable reliable supply of specialty care medicines by providing technical and scientific support to their licensure, ongoing commercial manufacturing, and life-cycle management (LCM) activities.

The MSAT Drug Substance (DS) function within our Sanofi biologics manufacturing network delivers innovative, robust, and cost-effective next generation processes and provides commercial manufacturing support. The function is also responsible for tech transfer activities including process fit-gap assessments, process validation, dossier sections preparation, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers multiple products, modalities and 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 platforms. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

The Process Engineer/Scientist Cell Culture is part of the Geel upstream team in the Drug Substance (DS) function within the global MSAT organization, thereby supporting Geel based production processes/projects as well as projects within the broader global Sanofi biologics network.

The opportunity:

Starting from thorough scientific and technical knowledge, you will contribute to Technology Transfer activities aiming at introduction/launch of new products and processes at the Sanofi Geel biopharmaceutical manufacturing site. Additionally, you will contribute to improvement & Life Cycle Management 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 of both.

Join Sanofi Geel as MSAT Process Engineer/Scientist Cell Culture and become part of our technology transfer team that scales up & implements Sanofi’s miracles of science to improve people’s lives!

Main responsibilities:

• Support and drive technology transfer, initial process validation (including process performance qualification) and process control strategy definition for introduction of new manufacturing processes for clinical and/or commercial manufacturing of biological drug substances
• 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
• Build a network and maintain good relationship with both internal (e.g. operations, quality,…) and external (suppliers, alliance partners, R&D, …) stakeholders
• Represent the Upstream team as an SME in cross-site, cross-functional and global teams and projects
• 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
  
  

Function in day shift (flexible working hour system), 40-hours/week

• About you
• 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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.