Chargement en cours

Convergence Leader, Dupixent Franchise Offer Acceptance (H/F)

VITRY SUR SEINE
il y a 2 jours

About the job

The mission: The Sanofi/Regeneron Alliance is a critically important collaboration to Sanofi. The two companies have jointly developed and commercialized several products with combined revenue forecasts > 10 billion Euros annually and expected to double in five years to >20 billion euros. This role is high impact and high visibility, collaborating with global leaders internally and externally. The Convergence Leader, Dupixent Franchise ensures efficient implementation of major changes across multiple sites, driving the performance and compliance of Dupixent while maintaining supply through the transition. The candidate will work with our external partner Regeneron and several sites in the network including, but not limited to, Geel, Bioatrium, Waterford, LeTrait, and Frankfurt BioCampus. The Convergence Leader drives the assessment, planning, and transition of CMC lifecycle changes endorsed by the Industrial Product team and the Regeneron Change Control Committee. The candidate ensures the changes are properly assessed for all markets, including the regulatory requirements, implementation timing, and supply transition plan; ensures the multi‑change, multi‑site strategy is integrated and designed; identifies risks and blocking points. The change status is monitored and updated; the plan is refreshed as needed. The approval status is communicated, and sites/functions are ready to implement. The candidate collaborates with experts in regulatory, quality, supply chain, and manufacturing operations as part of the convergence planning team, including Regeneron partners. Additionally, the Convergence Leader will establish automated processes and tools needed within the M&S Specialty Care organization and will work with colleagues in Supply Chain, IT, Quality, and Regulatory. The Convergence Leader, Dupixent, will lead the Sanofi internal Dupixent Convergence Committee, co‑lead the Regeneron/Sanofi Flavor Management Committee, and be a key member of the Joint Change Control Committee to ensure alignment of changes agreed within the alliance.

Main responsibilities

  • Accountable for driving and executing the Convergence Plan Process for the plans in his/her/their perimeter.
  • Accountable for preparing and leading the internal Convergence Plan meetings and the Regeneron joint meetings.
  • Closely collaborates with the IFL and IPLs for validation of the proposed scenarios, ensuring alignment with the industrial strategy and identifying potential evolutions needed.
  • Establishes, updates, and communicates Convergence Strategy and operational roadmaps for each contributing function (MSat, Manufacturing, GRA, etc.).
  • Prepares elements for risk escalation when needed.
  • Represents the Convergence Plan and ensures presentation of blocking topics for decision making.
  • Prepares synthetic communications on the Convergence Plan for functions or management (view by country, product, site, etc.).
  • Ensures a link between Regulatory Affairs, Quality, and other M&S functions, as well as the processes and committees linked to the management of change controls; provides a global and end‑to‑end vision of the product lifecycle portfolio enabling thoughtful decision making.
  • Leads the continuous improvement of the Convergence Plan process internally and externally (Regeneron).

About you – Education / Experience

  • School qualifications: Bachelors/Masters degree in a scientific or engineering discipline.
  • In‑depth knowledge of at least two of the following: (Bio) Process Technology, Manufacturing, Quality/Analytics, Regulatory requirements, Supply Chain, Project Management, and application thereof in commercial Biopharmaceutical Operations with a minimum of 10 years total industry experience.
  • Extensive leadership experience (minimum 5 years) in the biopharmaceutical industry within the field of bioprocess development or manufacturing.

Type de contrat / Salary

Type de contrat: CDI

Contrat travail: Durée du travail 40H/semaine, Travail en journée

  • Salaire brut annuel: 76,000.00 to 101,333.33 Euros over 12 months.
  • Plan d'actionnariat salarié
  • Plan d'épargne retraite d'entreprise
  • Intéressement / participation
  • Indemnité transports
  • CSE

Formation

  • Qualification : Cadre
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Entreprise
SANOFI WINTHROP INDUSTRIE
Plateforme de publication
WHATJOBS
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