M&S-IFB-Head of Buffer, Media & Utilities IFB

Job title: Head of Buffer, Media & Utilities IFB

About the job

Background

Sanofi has decided to invest into a new large state-of-the art facility insulin Drug Substances to ensure future oriented, sustainable, reliable and leading-edge long-term supply for Diabetes patients. The new facility will be designed as a fully automated, green, modern and state-of-the-art biologics facility considering specific process requirements of insulins. The localization of this facility will be in Beijing/China and is called Insulin Facility Beijing (IFB). This site 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 seeking a leader for the role of the Head of Buffer, Media & Utilities IFB, reporting directly to the Head of Operations IFB. 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 China. The successful candidate will work in close partnership with engineering teams to ensure the success of these state-of-the-art facility.

Main responsibilities

Represents manufacturing know how and operational knowledge in the project team with focus on the following items:

• Buffer preparation

• Media preparation

• Warehouse management

• Clean Steam

• Water for injection

• Tank Farm

• Waste Handling (excl. Waste water treatment)

• 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 buffer and media preparation and utilities implementation between the Frankfurt and China facility.

• 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

• Leading a team of 8-12 people

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

About you

Experience

• PhD (preferred) or master’s 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

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.

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