Section Head Technology Transfer and Process Knowledge Management - all genders

About the job

Our Team:

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Bioprocess Engineering Tech Transfer Team as Section Head Technology Transfer and Process Knowledge Management and you’ll contribute to the CMC development of new Sanofi products while enjoying lots of opportunities to broaden your experience and expand your skills.

As leader of our Tech Transfer team in the Bioprocess Engineering group in CMC microbial drug substance process development, you will manage a diverse team of technology transfer and process data experts in Frankfurt and Ghent working embedded in a multi-site organization. This role involves managing technology transfers in early development phases and important contribution to late-phase technology transfer processes. As an engaged and integrating leader, you will empower your team through clear communication, coaching and fostering a collaborative culture that drives both individual growth and collective success. You will collaboratively and constantly improve technology transfer ways of working and standards aiming at seamless transfer to various sites in R&D, to M&S or with external partners to keep project timelines and aim at first-time right technology transfers. In addition to this you will lead and coordinate process knowledge management for the site and in cooperation with other sites and stakeholders to improve ways of working by digitalization and automation and ensure data continuity throughout the project lifecycle.

Main responsibilities:

• Manage and develop a team of technology transfer and process data experts in Frankfurt and Ghent working within a multi-site organization
• As a member of the Bioprocess Engineering leadership team you will shape our end-to-end processes to maximize our process knowledge and ensure fast and high-quality process development up to process performance qualification.

Technology Transfer

• Oversee the technology transfer portfolio, adapting to changing priorities while ensuring proper setup of project teams at both sending and receiving sites with clear roles, responsibilities, and governance frameworks.
• Drive continuous improvement of technology transfer methodologies and standards for seamless transfers to various sites in R&D, M&S or external partners to maintain project timelines, incorporating digital solutions to achieve first-time right technology transfers.
• Ensure compliance with GMP regulations and internal quality standards throughout the technology transfer process and related activities.
• Continuously improve workflows for CMO management including process knowledge management, interface coordination with contract management and contribution to CMO selection decisions.
• Ensure timely delivery of all required documentation for technology transfer.
• Lead technology transfers and process knowledge transfers across multiple interfaces for early phase projects and contribute to late phase technology transfers, including coordination of sending unit and CMO oversight teams and integration of data and knowledge into Sanofi systems.
• Develop and lead project specific process control strategy within the platform in close collaboration with other development functions and MSAT as well as other technology transfer related activities.
• Additionally, team members also take on early-stage CMC project leadership for selected projects

Process Knowledge Management and Digital

• Lead and coordinate site-wide process data management in collaboration with other sites and stakeholders to enhance operational efficiency through digitalization and automation, ensuring data continuity throughout the development project lifecycle while aligning site specific activities with global digital initiatives.
• Drive evaluation, implementation and maintenance of new software, programming and AI solutions for Bioprocess Engineering.
• Maintain effective communication and governance with all project stakeholders, regarding process knowledge management.
• Lead troubleshooting initiatives for complex process issues, coordinate root cause investigations for deviations and support implementation of solutions in GMP environment.
• Drive continuous optimization of project plans for technology transfers, including gap analysis between sending and receiving units, communication protocols, reporting standards, risk management strategies, and provide regulatory submission support in coordination with sending and receiving units

Leadership

• Lead a highly motivated international team, develop their integrating and negotiating skills as well as driving talent development of individuals.
• Champion a learning culture and collaboratively develop best practices within the team for a more digital future
• Ensure and provide training of best practices for tech transfer procedures and process data management.
• Lead and participate in global cross-functional working groups critical for the development of the organization.
• Provide expert guidance to early phase CMC Project leaders in the team and support regulatory authority interactions as subject matter expert.

About you

• Ph.D. in biotechnology, bioprocess engineering, chemical engineering, pharmaceutical sciences or biology.
• 8+ years of experience in tech transfer and biologics process development in pharmaceutical or biotechnology industry.
• Expertise in at least one key CMC discipline for microbial-produced biologics (e.g. process development, manufacturing) beneficial
• Demonstrated success leading technology transfers for early and late phase projects, both internally and with CMOs as well as in-depth knowledge of standards and principles related to end-to-end technology transfer, like process control strategy, process validation, Quality by Design, risk assessment, scale-up, root cause analysis and troubleshooting tools
• Comprehensive understanding of end-to-end CMC project requirements, including budgetary and regulatory aspects
• Knowledge of regulatory requirements and GMP regulations, their application in process development and quality standards.
• Experience in implementation or use of new digital solutions and AI
• Technical background in data analysis, modelling tools and programming (Python, R, PowerApps) beneficial
• Proven experience with project and knowledge management methodologies
• Track record of demonstrated team leadership with excellent communication skills and problem-solving capability. Passionate about talent development and keen to foster a culture of collaboration.
• Experience leading cross-functional teams on complex projects with changing priorities and tight deadlines, aiming at a solution-oriented approach
• Ability to manage internal and external stakeholder relationships confidently
• Fluent in German and English, verbally as well as in writing.

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.
• Start your career at an attractive location in the center of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

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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