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).
Pursue progress. Discover extraordinary.
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Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
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