Laboratory Head non-GMP PP Tech Area - all genders

About the job:

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Our Team:

As Lab Head Tech area within our non-GMP Pilot Plant team, you'll be responsible for the set-up and lead of a Technology Area for the production of Biopharmaceuticals at technical scale. This includes Pioneering in the establishment of continuous production processes for microbial end-to-end Drug Substance processes (Upstream Processing and Downstream Processing), working at the interface between research, development and production. Ready to get started?

The non-GMP Pilot Plant Team of the Bioprocess Engineering Group is an integral part of the Microbial Platform within the global CMC development organization. Our core competency is the scale-up of processes for the production of drug substance using microbial systems, including the development of innovative process solutions at pilot scale. We contribute to bringing innovative medicines to our patients by supplying materials for dossier-relevant studies and providing crucial process data. In doing so, we combine various technical facilities and technologies in the areas of microbial fermentation and purification. So, if you are interested in advancing new technologies and shaping the future, become part of our growing team.

Main responsibilities:

• Responsible for the Set-up and Lead of the Tech Area of the non-GMP pilot plant for the production (USP) and Purification (DSP) of non-GMP technical Drug substance material and process intermediates from the microbial project portfolio (e.g., Nanobody® molecules, Synthorin™ molecules, plasmids).
• Identification, evaluation, and implementation of new technologies at technical scale with focus on pioneering continuous and disposable production processes. This includes feasibility assessment of GMP facilities with regards to robustness, performance, and selection or design of new production facilities.
• Self-reliant planning, scale-up, supply and analysis of technical material and troubleshooting for microbial projects in non-GMP technical scale.
• Characterization and evaluation of equipment and development of predictive models with regards to process scalability.
• Close collaboration with development units, the Heads of non-GMP PP (USP and DSP), GMP production, and being active representative for BPE in project teams and cross-functional initiatives.
• Introduction of electronic systems and AI solutions for the digitalization of processes, workflows, documentation and analysis of process-relevant production data
• Responsible for the organization, coordination and optimization of lab and process procedures in accordance with local and global guidelines as well as safety regulations (HSE) including the establishment of corresponding documents (protocols, safety evaluations, working procedures)
• Planning, execution, development and documentation of experiments including the related in-process analytical methods
• Securing the efficient and documented transfer of developed processes in GMP pilot plants and to other Sanofi sites including technical support and expertise
• Responsible for assigned facility maintenance and adaptation to new projects
• Collaboration in the preparation of regulatory documentation (e.g., contributions to IMPD/IND).
• Leading, motivating, and developing assigned employees according to our Sanofi values.

About You

Education and experience

• Advanced university degree (e.g. PhD or similar) in Natural Sciences or Engineering (Biology, Biotechnology, Chemical Engineering, or similar) and a minimum of 5 years of professional experience
• Experience in production (USP) and purification (DSP) of biologics with microbial systems
• Experience in the scale-up and with continuous production processes
• Experience with mammalian cell culture beneficial
• Experience with digitalization initiatives
• Experience in the identification, evaluation and implementation of new technologies
• Experience in leading teams with direct personnel responsibility and in a matrix organization
• Experience in project management in international and interdisciplinary contexts

Soft skills

• Strong teamwork and communication skills
• Excellent organizational skills
• Collaborative spirit for open exchange in crossfunctional teams
• Independent work style and solution-oriented approach
• High self-motivation, reliability, and sense of responsibility
• Pioneering spirit and willingness to continuously learn
• People leadership according to Sanofi values

Technical skills

• Extensive knowledge and professional experience with production processes for biological products, particularly in the area of production and purification techniques for various modalities
• Extensive process engineering understanding and knowledge in scale-up of cultivation and purification processes
• Experience with continuous production processes
• Knowledge in bioanalytics
• Programming skills and tools for data analysis and know-how in multivariate data analysis beneficial
• Knowledge in process digitalization
• Knowledge in process transfers
• Knowledge in implementing regulatory requirements and regulations, including in the area of GenTG (Genetic Engineering Act)
• Analytical thinking and approach
• Very good IT skills (MS Office) and knowledge in handling modern, IT-supported plant systems

Languages

• Excellent German and English skills, both written and spoken

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, 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.

PursueProgress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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