MSAT Process Engineer Purification

• Location: Geel

About the job

Our team:

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide.

Sanofi is an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

The Process Engineer Purification is part of the downstream team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science & Analytical Technology (MSAT) organization and is based at the Sanofi Geel biopharmaceutical manufacturing site. The position primarily focuses on manufacturing-scale activities but involves a strong collaboration with the laboratory team.

The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management (LCM) of mammalian cell culture based DS processes within the Sanofi biologics manufacturing network. We enable launch of new products, provide commercial manufacturing support and deliver innovative, robust, and cost-effective next generation processes. The function is also responsible for tech transfer activities including process fit-gap assessment, process validation, dossier sections preparation and PAI support to enable launch of new and LCM products. Our expansive portfolio covers multiple products, modalities and expression systems within various internal and external global sites. We will be supporting launch of multiple new products in next 3-5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates and nanobodies. We are also actively pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.

Main responsibilities:

Starting from thorough scientific and technical knowledge, you contribute to i) improvement initiatives and the monitoring of existing processes at the Sanofi Geel site and within the broader Sanofi network and ii) technology transfer activities, both transfer in and out, of new products and processes to large-scale GMP manufacturing facilities.

Your job will consist of manufacturing-scale activities related to:

• 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.

• Identification of process improvements, through deep process understanding and digital driven initiatives, to increase yield or process robustness, and generation of a supportive data packages leading to implementation at manufacturing scale.

• Supporting and safeguarding existing commercial production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process.

About you

• Soft and technical skills:

  • You have specific experience in protein purification (on lab- and/or manufacturing scale);

  • You are flexible, willing to adapt to changing priorities and willing to learn at a rapid pace;

  • You are flexible and a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments and sites;

  • You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail;

  • You have a strong technical background in terms of large-scale biotech manufacturing equipment;

  • You are familiar with various statistical and data trending techniques;

  • You have affinity with digital process monitoring systems (including handling of large online data sets) and data connectivity;

  • You like to work in team and consider yourself to be a good team player.

• Education: PhD or Master in Engineering or Life Sciences (or equivalent through experience)

• Languages: Excellent English and Dutch communication skills, both written and oral.

Why choose us?

• Contribute to the production of life-saving medications that improve patient outcomes worldwide;

• Engage with a global network of professionals and benefit from a culture that promotes teamwork and mutual respect;

• Supportive work environment that values employee wellbeing and possibility of remote work arrangements to support work-life balance;

• Engage in cross-functional collaboration with research and development, manufacturing and quality teams to bring new therapies to the market;

• Drive innovation and implementation of state-of-the-art technologies to enhance operational performance.