Purification Engineer Tech Transfer & Manufacturing Support - all genders

About the job

As a member of our Tech Transfer team in the BioProcess Engineering group in CMC microbial process development, you will manage drug substance process data and tech transfer projects. Implementation of digital solutions to ensure data continuity and knowledge management in cross-functional initiatives throughout all clinical phases is an essential part of the role. Leading internal tech transfer teams for development projects within R&D, with external partners or contributing to tech transfers from R&D to M&S sites, you bring in know-how for scale-up from lab to GMP manufacturing scale to support development and manufacturing teams.

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 Process Data and Tech Transfer Lead 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.

Main responsibilities:

Process Technology Transfer

• Lead technology transfer projects from research and development units to GMP manufacturing, internally and to or from CMOs, including facility fit assessment, gap and risk assessment and ensuring seamless process transfer, knowledge sharing and data continuum.
• Lead and collaborate with cross-functional teams to optimize processes for large-scale production.
• Reporting for all Technology Transfers

Process Development and Scale-up

• Apply engineering principles to develop and optimize scalable manufacturing processes, lead trouble shootings, deviation studies or scale-up initiatives
• Utilize scale-up principles to translate laboratory-scale processes to pilot and commercial-scale production.
• Collaborate with research teams to ensure process robustness and reproducibility at various scales.

Digital and Data Science Application:

• Responsible for process data management for projects with the support of all involved functions (Development, GMP manufacturing, and Analytics) focussed on non-GMP and GMP batches
• Utilize digital and data science tools to support analysis, troubleshooting, and transfer of biologics processes.
• Implement data-driven approaches for process optimization and control.
• Support of development and maintenance of databases and digital platforms to enhance knowledge management and tech transfer efficiency.

Process Modeling and Simulation:

• Develop and apply process models and conduct advanced data analysis
• Perform advanced calculations to predict and optimize process performance at various scales.

GMP Production Support:

• Provide technical support to GMP manufacturing teams during and after tech transfer.
• Ensure compliance with GMP regulations and internal quality standards throughout the tech transfer process.
• Troubleshoot process issues and implement solutions in a GMP environment.

Continuous improvement:

• Share best practices in tech transfer and implementation, in project management, and support continuous improvement and operational excellence initiatives
• Lead the Process Control Strategy for late stage projects, support submissions (e.g. IMPD/IND) and Inspections as Subject Matter Expert

About you

• Advanced university degree (Ph.D. preferred) in Bioprocess Engineering, Chemical Engineering or a related field.
• 8+ years of experience in tech transfer and biologics process development within the pharmaceutical or biotechnology industry.
• Strong background in engineering sciences, with expertise in scale-up principles, process control and digitalization and process modeling.
• Proficiency in data analysis and visualization tools (e.g., Python, R, Matlab, PowerApps).
• Experience with modelling and simulation software
• Ability to work effectively in a cross-functional team environment and experience leading cross-functional teams managing complex projects with tight deadlines and the ability to adapt to rapidly changing project priorities
• Strong communication and project management skills
• Fluent in German and English, verbally as well as in writing.

• Knowledge of GMP regulations and their application in process development, quality standards and regulatory requirements.
• Experience with Design of Experiments (DoE), Quality by Design (QbD) principles and process control strategy
• Analytical thinking and good documentation practice
• In depth knowledge of end-to-end CMC project requirements including budgetary as well as regulatory aspects

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.
• 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.

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.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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