Manufacturing Science and Technology MSAT lead Cell culture
About the opportunity
Join Sanofi Belgium as Manufacturing Sciences & Technology (MSAT) Lead Cell Culture and provide leadership to a team responsible for technical oversight and support of manufacturing activities within the global biologics network.
Your team will consist of Manufacturing Science (manufacturing scale oriented) colleagues.
In this role you will lead Lifecycle Management of commercial processes, Commercial Manufacturing Support and Technology Transfer.
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-gap 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.
The MSAT Cell Culture team is located in Geel and is part of the Global MSAT organization, thereby supporting Geel based production processes / projects as well as projects within the broader Sanofi biologics network.
About growing with us
Starting from thorough scientific and technical knowledge, in this role you will
Provide technical leadership to a team ( 5 people) of scientists / engineers / PhDs with a solid background in large scale cell culture processes
Ensure realistic planning and prioritization of activities, keep oversight of delivering on commitments
Lead and coach the cell culture manufacturing science team guide and develop each member of the manufacturing science team both in execution of their responsibilities and in their own personal development.
Maintain a high-performance team that fosters accountability, open communication and continuous improvement / development
Identify process improvement opportunities to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
Support and safeguard 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 provide technical advice to questions of other departments
Use a solid understanding of scientific principles and professional practices to solve a range of complex deviations and issues in manufacturing in creative and practical ways
Lead / support technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale if applicable
Support regulatory filings and health authority inspections
Work closely together with the Process Sciences (small scale) team
Build a network and maintain good relationship with both internal (e.g. operations, quality, ) and external (suppliers, alliance partners, ) stakeholders
Maintain and demonstrate significant knowledge of the state-of-the-art technologies
Represent the Upstream team as an SME or technical lead in cross-site, cross-functional teams
Required Skills & Qualifications
PhD or master in Life Sciences, with relevant experience of minimum 5 or 7 years respectively
Proven experience in leading and developing high-quality, high-performance teams of scientists and engineers of diverse academic backgrounds and skill levels
Experience in mammalian cell culture processes on lab- and / or manufacturing scale; experience with purification processes is a plus
Familiar with current Good Manufacturing Practices & US / EU regulations
Familiar with various statistical and data trending techniques
Ability to drive change, innovation, team work and competitive performance as well as develop, inspire and motivate a team in the achievement of specific objectives
Flexible and willing to support both manufacturing scale operations and support small scale lab studies
Strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
Excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
Oral and written fluency in English
International mindset ability to work in a multi-site global organization and willing to travel (at least for short term) abroad
Terms of Employment
Function in day shift (flexible working hour system), 40-hours / week
Proposed start date : ASAP
We recommend that you inform your manager if you are interested in this position.
Candidates can add a resume and motivation letter to the vacancy in Workday.
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.