Senior Manager, MSAT Laboratory

Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care biological products. One of these two Modulus sites is implemented in Singapore in a new Greenfield site, with a design like the one in Neuville (France). Our manufacturing sites are state-of-the-art, powered by big data and digital. It is the bridge between scientific advances and transformative medicines and will be serving millions of people around the world.

Manufacturing Science, Analytics and Technology (MSAT) drives the industrialization and the improvement of biological processes and products. It embarks new technologies and digital trends. It is the keeper of manufacturing process knowledge. MSAT is at the crossroad of R&D and production. It is a multi-disciplinary function that provides expertise in process, manufacturing sciences, process modeling, statistical analysis, process validation and technology transfer.

The MSAT team in Sanofi Modulus Singapore is seeking a Senior Manager, MSAT Lab. This person is accountable for upstream, downstream and analytical laboratory activities which support troubleshooting and lifecycle management initiatives for commercial biologics production. This role will set up the laboratory, hire & develop the laboratory scientists to support manufacturing investigations through laboratory studies and data analysis as well as drive continuous improvement projects. A crucial part of the role is also to continuously review and bring in innovative capabilities and automation technologies to enhance laboratory operations & large-scale process efficiencies.

Duties & Responsibilities

Lab design & operations:

• Hire, train & develop competent scientists for laboratory operations.

• Lead laboratory set up project, with support from sending unit on equipment & operational requirements, while keeping within budget, timelines, Modulus vision and Sanofi standards (e.g. Eco-design, HSE, iCMC).

• Establish & ensure laboratory workflows & SOPs, laboratory equipment qualification and maintenance programs, as well as personnel training are compliant with HSE & GLP requirements.

• Establish laboratory operations & resource deployment for timely manufacturing assistance.

• Establish, track & manage performance of scientists & laboratory activities.

• If needed, work with external interim laboratory to set up laboratory activities for business continuity.

Manufacturing support & troubleshooting:

• Support technology transfer activities by planning & executing small/mid-scale laboratory work such as improvements or data generation.

• Participate in cross-functional teams to address manufacturing challenges.

• Lead complex manufacturing investigations by delivering/guiding team to design and execute laboratory studies.

• Author and execute plans, protocols, interpret data and generate reports.

Lifecycle management & process efficiency improvements:

• Lead site projects involving key process changes, new technology introduction to mature state before at-scale implementation. May lead network-level projects.

• Identify trends, assess potential causes and propose & own continuous improvement initiatives, including working cross-functionally within the site and network.

• Provide expertise & lead laboratory activities to support process changes & optimization.

• Author documentation to support change management, including risk assessments and mitigation strategies if necessary.

• Support regulatory filings related to process changes & improvements.

• Monitor industry trends and regulatory landscape to proactively suggest process enhancements.

Networking & external innovation:

• Build and promote systems and tools for (i) standardization concepts & implementation, (ii) sharing and retention of design knowledge, within site and Sanofi network.

• Contribute to the development & deployment of best practices and standard operating procedures across the Sanofi network, including engagement with equipment vendors and external partners.

• Lead/ support activities on external innovation partnerships.

• Is a domain expert at site, or network key opinion leader.

Pre-requisites

Knowledge, Skills & Competencies

• Strong people & project leader with strategic vision, scientific know-how and operational mindset.

• An effective communicator and productive in multi-functional & multi-cultural communication settings.

• Has excellent analytical, consultative and diagnostic skills with ability to make sound, data-based business decisions. Is scientifically curious.

• Self-directed and comfortable working with a high level of autonomy, for initiating activities to close gaps and complete assigned tasks.

• Some proficiency in DOE experimental design, high throughput operations and data analysis.

Qualifications

• Holds a scientific or engineering degree (or higher), preferably in Biotechnology, Biological Sciences, or Chemical Engineering.

• Experience in aspects of small/intermediate-scale mammalian cell culture, purification and/or analytical studies like authoring study plans, executing study protocols, interpreting data and generating reports.

• Experience in managing biotechnology laboratory and scientific personnel, with GLP and laboratory safety concepts.

• Has successful broad industrial experience in mammalian biopharmaceutical projects, particularly in process development, process engineering, technology transfers, process validation and/or manufacturing support.

• Some familiarity with cGMP concepts in biopharmaceutical environments and up-to-date with current industry trends and emerging technologies in biologics manufacturing, regulatory requirements, industry best practices and experimental design.

Play to win behaviors

• Stretch to go beyond the level we have operated at up until now

• Take Action instead of waiting to be told what to do

• Act in the interest of our patients and customers

• Think One Sanofi: we put the interest of the organization ahead of ourselves or our team