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Technical Development Director, Formulation Development (345358BR)

Business Development

Director

Yearly

No

Princeton, New Jersey, United States

$500 million! That’s the savings Sandoz has provided in just two years to the US healthcare system as a result of the successful adoption of one of our oncology supportive care biosimilar into clinical practice. Sandoz has eight biosimilar approved globally – including four in the US – and more than ten in the pipe-line. Biosimilar may enable more patients to access advanced biologic medicines earlier, and Sandoz has proven that biosimilar offer significant savings for overburdened health systems. We are looking for curious, innovative, driven people to help us get these products into the market. Maybe that’s you.<br><br>Your responsibilities will include, but are not limited to: <br>• Influence product strategy and executes, product development activities related to formulation / transfer with external BD partners (incl. CMOs, CDMOs) and lead alignment with CMC sub-team.<br>• Owns the delivery of product development initiatives/projects for the development of NDAs, 505(b)(2)s, generic ANDAs (505j) and some OTC/Consumer Products through various milestones of product development.<br>• Be the partner of reference to lead opportunities related to due diligences (DD) for in-licensing or acquisition of products and related assets (dossiers, technology, etc.). This includes a thorough review and understanding of the offered products’ characteristics and performance based on quality attributes, robustness of formulation and manufacturing processes, and life cycle of the asset.<br>• Apply high quality standards/ principles during the different stages of product development, including review of drug product characterization, raw material quality attributes, drug-device compatibility, design of experiments, stability testing, product / process optimization, and statistical evaluation of data.<br>• Leading engagements with the regulatory agencies, including Complex Gx product development and pre-submission meetings for related projects in scope.<br>• As part of project responsibility also prepare DD reports and summarize and communicate the findings concisely. <br>• Proactive management of project risks, opportunities and establishing comprehensive mitigation plans when it comes to product development/technical challenges. Establish project plan baselines and document assumptions. Compile and challenge project schedules with the project team, manage timelines through critical path analysis, monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes. Manages project Budgets, Contract Milestones and Spend and provide updates on a monthly basis to the Product Development Senior Leadership. Performs data-entry function on project timelines, project status report and management dashboard.<br>• Leads and collaborates with other functional area Subject Matter Experts (SMEs) to perform target evaluations, while maintaining confidentiality requirements of due diligence.<br><br><br>This position will be located at the Princeton site and will not have the ability to be located remotely. This position will require 25% travel as defined by the business (domestic and/ or international).<br><br>[#video#https://www.youtube.com/watch?v=8ZgyAWo0yg8 {#400,300#}#/video#]