Drug Product Industrialization Lead, Lyophilized Product

• Location: Waterford, Ireland

Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

In our MSAT Injectable Platform, we are looking for a driven and motivated leader for the role of Drug Product Industrialisation Lead, Lyophilized product. The incumbent will lead ~3-5 projects/products, from the scientific, strategic and execution standpoints, within Sanofi’s vial and cartridge-based Biologics Drug Product (DP) portfolio. This portfolio comprises a broad diversity of products, from late-stage development, launch-ready to commercial products. The role spans MSAT DP operations for Contract Manufacturing Organizations (Worldwide) and for the Waterford site.

Main responsibilities:

• Strategic lead of New Product and LCM activities of commercialized drug products with M&S sites, as well as with CMOs and external partners  
• Define and update the process control strategy 
• Contribute to define project plans and risk matrix  
• Assure that project activities and commitments are fully supported and provide overall scientific/technical support, expertise, and guidance to manufacturing and quality in aseptic injectable drug product manufacturing that results in safe, high quality products that are continuously improved
• Interact with colleagues from various site functions, in particular manufacturing, quality, facilities, engineering, and automation departments, as well as other departments within the Sanofi Lyophilization network, or with CMOs and External partners, to ensure robustness of manufacturing operations  
• Keep abreast with new developments and technologies in areas of responsibility.
• Provide input to regulatory dossiers, provide responses to questions from authorities 
• Scientific lead for troubleshooting activities
• Support in Sanofi product sourcing and divestment, by identifying and evaluating potential new CMOs

About you:

• Experience:
  • PhD or Master in science (University), Pharmacy, Biochemistry, Biotechnology 
  • 10+ years of professional experience in development and manufacturing of pharmaceutical products, preferably in drug product development, manufacturing and quality 
  • Proven track record of successful experience with CMOs can be beneficial, as the role will cover a large portfolio managed through CMOs.
  • Embrace change and innovation and initiate new and improved ways of working 
  • Ability to deal with ongoing ambiguity and complexity, strive for resolution and simplification 
  • Capable to engage senior site and functional management and collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results 
  • Ability to work in International/global environment 
  • Effective communicator at all technical, interpersonal and business levels, ability to synthesize and explain complex topics to non- experts and to management/stakeholder
  • Anticipating risks and potential product issues and proactively leading effective and innovative resolutions 
  • Long term experience in injectable drug product development and pharmaceutical engineering, transfers, validation and industrialization of manufacturing processes, regulatory requirements, dossier writing, cGMP knowledge, HA regulations, quality systems… 
  • Strong skills in project management tools and execution 
  •  English: fluency in English is essential for communication, documentation and collaboration with global teams and stakeholders
  • Additional languages: knowledge of other languages can be beneficial as the role covers a large geography (e.g. French, German and Italian).

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