Head of Manufacturing Sciences & Technology Purification, Geel, Belgium

工作内容

About The Opportunity

Join Sanofi Belgium as the Head of Manufacturing Sciences & Technology (MSAT) Purification 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 Process Science (lab study oriented) and Manufacturing Science (manufacturing scale oriented) colleagues.

In this role you will also lead Tech Transfer, Process Validation, Lifecycle Management and Commercial Manufacturing Support.

About Sanofi

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence. We want to focus on those areas where we know we are making a difference.

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 Purification team is located in Geel and is part of the Global MSAT organization, thereby supporting Geel based projects as well as projects within the broader Sanofi biologics network.

About Growing With Us

In this role you will….

Provide technical leadership to the team of scientists/engineers/PhDs with background in development and validation of purification processes.

Ensure resource planning and prioritization of activities, oversight of delivering on commitments in respective area

Coach and develop the MSAT Team (team of 20+) - mentor and develop each member of the MSAT team both in execution of their responsibilities and in their own personal development. Establish a high-performance team that fosters accountability, open communication, people development and continuous improvement

Lead technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale

Develop second-generation processes for existing commercial products using small scale models for studies conducted in lab environment

Identify process improvements 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 provided technical advice to questions of other departments

Support regulatory filings and inspections

About You

Qualifications/ Education & work experience

• Master or PhD degree in Biological/Biomedical, Sciences/Engineering
• 10+ years of biopharmaceutical industry experience in process development, process scale up/manufacturing and process validation
• Experience with large scale manufacturing support for mammalian cell culture processes, current Good Manufacturing Practices, US/EU regulations
• Experience with Tech Transfer and post approval life cycle management
• Proven experience in building, leading and developing high-quality, high-performance teams of scientists and engineers of diverse academic backgrounds and skill levels
• Ability to work in cross-functional and multi-site teams within a global matrix organization
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Ability to communicate effectively with internal and external stakeholders on status, needs, forecasts, risks and timelines
• Ability to drive change, innovation, teamwork and competitive performance as well as develop, inspire and motivate a team in the achievement of specific objectives
• Strong verbal and written communication and prevention skills
• Oral and written fluency in English
  
  

Inspire your Journey: what Sanofi can offer you:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
• An individual and well-structured introduction and training when you onboard.
• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
• As a globally successful and constantly growing company, Sanofi provides international career paths as well.
  
  

This is our Sanofi. Discover yours.

If you feel you have the required experience, please apply NOW! Alternatively contact maria.kmetyova-ext@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

Own your future. Make your move!

We are proud to have been awarded Global Top Employer 2021!

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.