Product Lead

Contenuto del lavoro

SC-MSAT Product Leads are end-to-end (drug substance through drug product fill/finish operations) technical representatives who drive lifecycle management agendas/portfolios for assigned products within specific product portfolios/clusters led by SC-MSAT Business Partners (product clusters are currently made up of Rare Diseases, Rare Blood Disorders, Immunology, Oncology, and Dupixent). Each of the product portfolios/clusters contain products in various phases including late stage development, launch, and commercial that are in active lifecycle management with second generation products. Together with SC-MSAT Business Partners, SC-MSAT Product Leads and their DS, DP, Analytical and other technical counterparts, provide timely and robust technical support from SC-MSAT to internal and external manufacturing sites associated with specific assigned products. The manufacturing sites that are supported may be internal sites (Framingham, Allston, Geel, Vitry, Lyon, Frankfurt, Waterford, etc.) or external sites (CMOs such as Lonza, Biogen, etc.), or external alliance partnerships such as BioAtrium and Regeneron. In association with assigned products, this role supports new product introductions, second generation programs, and other lifecycle management process improvement programs, process validation and comparability strategies, PAIs and regulatory dossier preparation, and other activities needed to meet IA SC technical and business strategic plans under the overall direction of SC-MSAT Business Partners. SC-MSAT Product Leads chair, attend and/or present at various strategy, governance, or technical forums and meetings as representatives of SC-MSAT. The primary responsibility for SC-MSAT Product Leads is to lead the operational aspects of the Technical Product Team (TPT) meetings to drive DS, DP, and Analytical technical and strategic agendas and provide technical/strategic direction to TPT team members while being supported by Project Managers who facilitate the TPT meetings. Effective leadership of TPTs ensures product compliance, operational risk identification and mitigation, continued commercial supply, and alignment to regulatory submission plans during the lifecycle of the product. In collaboration with the SC-MSAT Business Partners, oversees the execution of product roadmaps and operational plans, including prioritization of critical projects aligned with product drivers, long-term capacity and supply planning, long-term regulatory strategies, product lifecycle decisions, etc. SC-MSAT Product Leads are responsible for one major or several products depending on product complexity. SC-MSAT Product Leads will primarily focus on traditional biologic product technologies; however, flexibility to accommodate other modalities, working with other technical experts, is required of this role.

Scope and responsibilities of this role include:

Products, Modalities and Manufacturing Technologies:

• Supports assigned products in specific product portfolios/clusters within the IA SC perimeter
• Ability to acquire broad technical expertise across a diverse set of modalities including recombinant enzymes, blood factors, monoclonal antibodies, antibody-drug conjugates, bi-/tri-specific antibodies, polyclonal, nanobodies, and RNAs
• Expertise in a range of legacy to state-of-the-art manufacturing platforms including fed-batch and continuous manufacturing processes, large scale and intensified scale manufacturing, various host expression systems based on mammalian and microbial cell lines, a variety of purification unit operations/resins and filtration, and associated analytical technologies/methodologies
  
  

Manufacturing Site Support:

• Understands site priorities and portfolios and contributes to site prioritization and process & product performance improvements as required
• May support local sites or CMO sites to provide technical support or support other SC-MSAT personnel co-located at specific sites (for example, SC-MSAT Tech Leads)
  
  

Industrial Product Teams, CMC Development and CMC Regulatory Teams:

• Collaborates with Industrial Product Leads (IPLs), CMC Development, and CMC Regulatory personnel, etc. to ensure alignment of LCM activities with SC-MSAT plans and prioritization
• As part of the SC-MSAT Technical Product Team structure, helps develop technical project portfolios associated with a set of product(s) with support from various SC-MSAT functions and ensures their alignment to the product master plan(s) and strategic plans
  
  

Process Lifecycle Management:

• Participates in the design of process validation and comparability approaches for all aspects of biologics processing considering current regulatory trends together with appropriate SC-MSAT technical functions
• Maintains solid knowledge and understanding of evolving technological and regulatory policies and guidelines; seeks to adopt or establish industry best practices and network standardization
• Supports registration strategies/activities (submissions, briefing documents, regulatory responses, etc.) to meet global regulatory requirements by leveraging acquired technical expertise and biotechnology industry experience and to ensure timely and right-first-time approval in global markets including regulatory inspection support for new product/processes
  
  

SC-MSAT Organization:

• Seeks alignment of SC-MSAT portfolio with process lifecycle management projects to support product master plans and manufacturing site performance plans
• Empowered voice for specific products within IA Specialty Care Product Portfolios/Clusters
• Provides input to best practices related to process lifecycle management to SC-MSAT Business Partners and technical functions in SC-MSAT (DS, DP, Analytical) and CMC Development
  
  

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.