Background

Sanofi has decided to invest into new large state-of-the art facilities for the full portfolio for insulin Drug Substances to ensure future oriented, sustainable, reliable and leading-edge long-term supply for world-wide Diabetes patients. The new facilities will be designed as a fully automated, green, modern and state-of-the-art biologics facility considering specific process requirements of all insulins. The localization of those facilities will be in Frankfurt, Germany and Beijing, China. China is a completely new DS site without any legacy experience, operational workforce and knowledge on Biotech manufacturing need to be built from scratch. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Position Overview

We are looking for the position of a Team Lead within the Workstream Buffer, Media & Utilities (BMU) to secure with his team the timely preparation of Buffer and Media for the concerned process steps.

The Team Lead reports directly to the Head of BMU for the IFB project of the InsuLINK program.

This position will play a crucial role in supporting the design, planning, construction, start-up, and operation of the buffer and media preparation of our new state-of-the-art insulin manufacturing facility in Beijing, China. The successful candidates will work in close partnership with engineering and quality teams as well as the process experts from Frankfurt, Germany, to ensure the success of these state-of-the-art facilities.

After commissioning the team lead will coordinate and organize a team of up to 10 people to secure buffer and media supply in time, with the right quality and under GMP conditions.

Main responsibilities

• Represents Buffer, Media & Utilities know how and operational knowledge in the project team with focus on the supporting systems for the insulin process from large volume fermentation in Upstream to final purification in Midstream up to Downstream

• Supports and oversees the project tasks during different phases of the engineering/construction project, e.g. planning and design, P&ID review, HAZOP, ….

• Supports harmonization of processes and technologies between the Frankfurt and China facilities

• 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

• Involved in C&Q/OQ/PQ/PPQ

• Ensures that all product quality standards (biologics regulations) are implemented for the area of his responsibility

• 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

• Build the buffer & media preparation operational team and supports strategic workforce planning

• Partnership with MSAT on technology transfer and scale-up activities, collaborate efficiently in highly cross-functional teams

About you

Experience

• Bachelor's or master's degree in chemical engineering, Biotechnology, Bioengineering or related education

• >3 years industrial experience in the pharmaceutical business

• Technical background in the operation of large-scale chemical or biochemical equipment

• Knowledge of cGMP and regulatory requirements

• Experience in leading and upskilling of teams, talent management and knowledge transfer would be desirable

Skills

• Ability to work as part of a team in a continuously changing project environment

• Ability to manage high complexity of many 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

• Communication skills on a high level

• Good English writing and speaking skills

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.

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