Head of Microbial Platform Bioprocess Engineering - all genders

We are 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.

Within R&D, Global CMC Development, responsible for all aspects of biologics CMC, is a key enabler of Sanofi’s growth aspiration through its mission to develop manufacturing processes, formulations, and analytical methods as well as to scale up and manufacture clinical trial material. Developing new and disruptive technologies is our passion.

About the job

In order to accelerate our ambition to become an industry leader in this field, we are seeking to hire the Global Head of BioProcess Engineering (BPE) who will report to Global Head of Microbial Platform. The Global Head of BPE will be responsible for all aspects of non-GMP technical pilot plant operations, process technology transfers internally and externally, as well as internalization of in-licensed projects from CMO(s) or external partners, completing facility fits, and evaluation of scale-up/down of our fermentation and purification processes used in our GMP manufacturing network against pre-established success criteria.

• Non GMP Pilot Plant Operations: State of the art pilot plant equipment and operations to support production of early supply batches for process consistency, supplying material for execution of non-clinical studies and process development activities as well as testing and implementation of new manufacturing and process analytical technologies
• Facility Fit: Process Fit activities including equipment characterization and scale-up studies to ensure fermentation and purification processes developed by our process development teams are aligned with our internal and external manufacturing network
• Process Technology Transfer: Lead process technology transfer activities to ensure processes developed by our process development teams would run as planned and produce material with desired quality attributes upon transfer and/or scale-up of processes to our internal or external manufacturing network. Support of transferring in processes from CMO(s) or external partners to our internal manufacturing network and process development teams,
• Process Technology Platform: Lead complex deviation studies and task forces, provide lessons learned for platform evolution, develop and own Process Control Strategy frame, contribute to late-stage CMC project team as DS-Team representative
• Building Process Knowledge: Scale-up/Scale-down assessment of processes to include data collection and interpretation at small, pilot and GMP manufacturing network via development of templates, and advanced data analytics toolbox and driving implementation globally
• Interface to Research: Establish and improve ways of working at the interface to LMR, contribute to joined technology innovation roadmap with an E2E view of microbial portfolio
• Digital ambition and Knowledge Management: Implement and secure data continuum with an initial focus on batch data to provide one source of truth for all data dependent activities, own digital transformation within the platform for technology transfer and non-GMP PP eBR
• Innovation: provide assessment of new Technologies, promote Eco-Design, and pioneer implementation at relevant scale

About you

Experience:

• 10-15 years of relevant industrial experience
• Demonstrated ability to develop processes for therapeutic proteins or different modalities (nanobody-drug conjugates, fusion proteins, cytokines, antigens, posttranslational modifications, multispecifics, etc.) at any stage of development (clinical and commercial process development)
• Demonstrated passion for scientific innovation through patents, publications and presentations
• Experience in transfer of developed processes to clinical and/or commercial site, and scale up
• Experience with process modelling/process controls, using mathematical/statistical approaches
• Development of products leading to successful regulatory approval, demonstrating a thorough knowledge of regulatory requirements from various health authorities
• Leadership of CMC team(s), demonstrating knowledge of various aspects of drug development
• Sound knowledge of related areas such as protein engineering, purification, analytical sciences, formulation, data sciences, informatics, etc

Soft and technical skills:

• Demonstrated ability to communicate well in written form and orally with ability to explain strategy to teams and stakeholders

Education:

• Ph.D. in Natural Sciences, Chemical/Biochemical Engineering, or a related field

Languages:

• English, German

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career
• Shape the future of Microbial Platform via helping to develop and knowledge/technology transfer robust processes and supporting new technology development and implementation
• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
• We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
• Start your career at an attractive location in the center / in the capital of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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