Process Engineer/Analytical Dev Sp II

Position Title

Manufacturing Science and Technology - Process Engineer/Scientist Purification

Location

Geel (Belgium)

Department Description

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.

Job overview

Starting from thorough scientific and technical knowledge, you contribute to the start-up of new production lines, and improvement and monitoring of existing processes at the Sanofi Geel site and in the broader Sanofi network.

Responsibilities

• Development of second-generation processes for existing commercial products using small scale models for studies conducted in lab environment
• Technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale
• Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
• Supporting and safeguarding existing 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 and provided technical advice to questions of other departments.

Required Skills & Qualifications

• You have a PhD or master in Life Sciences, with relevant experience of minimum 3 or 7 years, respectively, in process development or MSAT-like functions
• Since all writing is in English and given the international context, you are fluent in writing and talking in English
• You have specific experience in protein purification on lab- and/or manufacturing scale; experience with growing mammalian cells in bioreactors is a plus
• You are flexible and willing to support both manufacturing scale operation and set up small scale lab studies
• You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
• You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
• You are familiar with various statistical and data trending techniques
• You like to work in team and consider yourself to be a good team player.

Terms of Employment

• Function in day shift (flexible working hour system), 40-hours/week
• Proposed start date: ASAP

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.