Sr. Engineer Process Development

• Location: Amsterdam, the Netherlands
• This is a fully onsite role in Amsterdam and would require a relocation to the Netherlands
• Job type: Permanent, Full time

About the job

Our Team

We have a new opportunity in our Cell Therapy site based in Amsterdam as Sr Engineer  Downstream Process Development. As a key member of the PM21 team you will play an important role in developing robust and scalable processes to support the innovative cell therapies. Sanofi is leveraging the natural strengths of human immune systems to source the best cells to produce innovative therapies for life-threatening disease. We are focused on Natural Killer (NK) cell research & development to maximize the potential of NK cell therapeutics. Join us to further fuel innovation in our current pipeline and support our goal: to help patients in need. When it comes to life-threatening diseases, we are one family.

Main responsibilities

• Lead process tech transfer activities of new or improved versions of the process from development to manufacturing
• Liaison between process development and manufacturing
• Initiate, lead and execute medium to large size CMC projects within cell therapy process development
• Working closely with the USP and DSP development teams as well as QA, RA, AD and other ensure timely delivery as well as technical success of the project
• Lead and support C(D)MO activities
• Setup and maintain collaboration with other Sanofi sites
• Author and review relevant technical documents, reports, procedures, manufacturing batch records and CMC sections of regulatory submissions (IND, BLA and similar)

About you

• MSc. or PhD in Cell Biology, Biotechnology, Process Engineering, or related field
• Hands-on industrial experience in biopharmaceutical process development / CMC
• Experience in representing process development in CMC teams for early and late stage development projects
• Expert in cell culture and/or purification technologies
• Experience with project management
• Experience with process transfer and/or process validation
• Experience with regulatory filings (BLA, IND, MAA) is a pre
• Experience with cGMP is a pre
• Fluency in English
• Team player
• Analytical thinking, well organized

Pursue progress. Discover extraordinary.

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, disability, or gender identity.

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