Job title: USP Team Lead Insulin Facility Beijing (IFB)

• Grade: L3.2

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Position Overview

We are seeking an experienced and strong USP Team Lead for our construction project IFB in Beijing reporting to the global head of USP of the program. This position will play a crucial role in supporting the design, planning, construction, start-up, and product implementation of our new state-of-the-art insulin manufacturing facility in Beijing, China. The successful candidate will work in close partnership with engineering teams.

Main responsibilities:

• Represents manufacturing know how and operational knowledge in the project team with focus on the Insulin process of volume recombinant E. coli fermentation and subsequent upstream manufacturing steps
• Supports and oversees the manufacturing project tasks during different phases of the engineering/construction project, e.g. planning and design, P&ID review, HAZOP, ….
• Supports harmonization of upstream processes and technologies between the Frankfurt and China facilities.
• Supports know how transfer to the greenfield program in China for the process implementation.
• Partners and collaborates with engineering during different project phases:
• Review and approve equipment and system designs
• Support vendor selection and equipment procurement
• Develop standard operating procedures (SOPs) and operational documentation
• Support developing training programs for staff
• Participate in equipment and system commissioning
• Establish user requirements relevant for the process
• Partners in OQ/PQ/PPQ execution for manufacturing of insulin DS
• Ensures that all product quality standards (in particular biologics regulations) are implemented for the process steps.
• Supports the implementation and translation of process control strategy, microbial & contamination control strategy, filter and single use concepts into operational processes.
• Participates and supports authority interactions.
• Supports strategic workforce planning for the Operations Team
• Partnership with MSAT on technology transfer and scale-up activities, collaborate efficiently in highly cross-functional teams

About you

Experience

• PhD (preferred) or Masters degree in Chemical Engineering, Biotechnology, Bioengineering or related
• 5 years industrial experience in the pharmaceutical business including 3 years in project or operational leadership positions with strong focus on insulin or biologics manufacturing
• Strong technical background in microbial manufacturing and/or development
• Strong knowledge of cGMP and regulatory requirements
• Understanding of concepts of automation, PAT technology and online analytics as well as experience in digitalization concepts
• Experience in upskilling of organizations, talent management and knowledge transfer

Skills:

• Ability to work under high pressure in a continuously changing project environment
• Ability to manage high complexity of a large number of interfering activities
• Ability to work in a highly matrix driven project environment with strong functional reporting lines
• Leadership capabilities for both functional and direct reporting teams
• Excellent teamwork skills to ensure efficiency during conversations, projects, meetings
• Strong technical networker capabilities
• Ability to closely collaborate and build cross-functional bridges
• Excellent communication skills
• Good English writing and speaking skills

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.

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!

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, ability or gender identity.

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