Principal Scientist, Purification Process Engineer - Tech Transfer and Production Support

Sanofi; Vitry-sur-Seine; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading biopharmaceutical company in Vitry-sur-Seine is seeking a Principal Scientist, Purification Process Engineer. You will lead technical transfer activities and provide expert support for downstream processes within GMP manufacturing. This role requires experience in biologics manufacturing, excellent communication skills, and an engineering degree in a relevant field. Join us to push boundaries in science and improve lives.

Prestations

Health and wellbeing benefits

At least 14 weeks of parental leave

Qualifications

• Experience in manufacturing or process development of biologics.
• Experience in writing/revising documentation for cGMP.
• Experience in defining process control strategy and validation.

Responsabilités

• Lead technical transfer activities and provide technical support.
• Support GMP manufacturing operations as SME for processes.
• Gather and compile process data for development runs.

Connaissances

Leading matrix teams

Data analysis

Excellent communication

Experience with biologics

Formation

Engineering Degree in Chemical Engineering, Biochemistry, Biotechnology

Description du poste

About the job

As Principal Scientist, Purification Process Engineer within our BioProcess Engineering (BPE) team, you'll lead technical transfer activities and provide expert support for downstream processes across our GMP manufacturing network. Ready to get started?

The BioProcess Engineering team, an integral part of the Mammalian Platform unit, specializes in pilot-scale batch manufacturing and seamless technical transfers to commercial production facilities. We bridge the gap between process development and large-scale manufacturing, ensuring robust and scalable purification processes that meet the highest quality standards for our innovative biologics portfolio.

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.

Main responsibilities :

This role is accountable for rigorous and efficient transfer and implementation of processes across the Sanofi GMP manufacturing network and CMOs (Contract Manufacturing Organizations), according to the program timelines.

Responsibilities include but are not limited to partner with all relevant functions from R&D and M&S (Manufacturing&Supply) to perform facility fit assessment, GMP operational readiness assessment, and authorize transfer documents, specifically :

• Lead technical transfer activities including facility-fit assessment and operational readiness assessment and provide technical support as SME (Subject Matter Expert) for processes (mainly DownStream Process)
• Support GMP manufacturing operations
• Act as DS lead (Drug Substance lead), whenever necessary, for any programs from Cycle 1 to Cycle 3
• Act as a data steward by gathering and compiling process data for projects with the support of all involved functions (Development, GMP manufacturing, and Analytics) for development runs, scale-up batches at technical pilot plant, and GMP batches at GMP manufacturing including process performance attributes and analytical results. Visualization for reviews, assessments, and process anomaly root cause analysis
• Lead evaluation and implementation of new process platforms and manufacturing technologies

About you

Experience :

• Experience in leading matrix teams
• Experience in manufacturing or process development of biologics, preferred produced in recombinant protein purification systems, with knowledge on scale-up, process transfer, and cGMP manufacturing operation
• Experience in writing and revising protocols, procedures, reports and other process related documentation as necessary to support process scale-up, transfer, and implementation to cGMP manufacturing operations
• Experience in defining process control strategy and process validation and performing risk assessment following the QbD principle
• Experience in Data Analysis using existing tools and willing to develop / evaluate new ones in the context of the global Digitalization strategy

Soft skills :

• Excellent oral and written communication skills to build relationships both inside and outside the company
• Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities

Technical skills :

• Working knowledge in recombinant protein GMP quality standards and regulatory requirements

Education :

• Engineering Degree in Chemical Engineering, Biochemistry, Biotechnology, or related field with industrial experience in manufacturing or process development of biologics

Languages :

• Fluent in English, French speaking in writing, reading and presenting

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
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks\' gender-neutral parental leave

Pursue Progress. 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.

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Better is out there. Better medications, better outcomes, better science. But 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. So, let\'s be those people.

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

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