At Lonza, we know the stakes are high for cell and gene therapy developers, and time-to-market is critical. That's why greater process efficiency, solid regulatory expertise, and having future scale-up in mind are vital. To maximize our customers chance of success, we've crafted a series of GMP solutions for cell and gene therapy based on these core principles. Using TheraPEAK Products customers can better plan the development of their therapy, from discovery right through to commercialization. (Depending on team structure, this role may report to a Senior or Associate Director product manager).
Critical to this is;
" Product Line Strategy: Lifecycle management, innovation strategy and process, and pricing.
" Sales and Operations Planning and Performance Insights: Product forecasting and inventory management, portfolio and customer performance, and deep portfolio understanding.
" Marketing planning: Support the development of the marketing strategy and provide technical input.
" Product Sales & Support: Drive technical awareness in supporting teams and provide second-line non-routine technical, business, and regulatory support coordination.
Safety/Compliance: Manage the safety and regulatory requirements of the assigned portfolio, supporting CAPA and change control commercial activities.
Responsibilities:
Product Line Strategy:
Sales and Operations Planning and Performance Insights:
Marketing Planning :
Product Sales & Support:
" Generate technical awareness in the appropriate departments to handle routine customer concerns quickly.
" Respond directly to non-routine technical, business questions, and regulatory questions.
" Support the sales and service teams through customer visits and regular communication, including participation in regional and global sales meetings.
" Actively drive training of service and sales representatives to sell and support the product portfolio on technical and regulatory aspects.
Safety/Compliance:
" Manage the safety, FDA, ISO 9001:2015, and other regulatory requirements of the associated production sites and legal entities.
" Join Deviation Review Board Meetings.
" Support Change Control and Corrective and Preventive Actions driven by Quality.
" Work with sales and marketing for customer communication and positioning.
Education and Experience: