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Technical Development Director, Analytical Development

Business Development



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 analytical development/ transfer with external BD partners (incl. CMOs, CDMOs) and lead alignment with CMC sub-team.<br>• Owns the delivery of product development initiatives/projects with emphasis on analytics for the development of NDAs, 505(b)(2)s, generic ANDAs (505j) products through various milestones of product development.<br>• Be the partner of reference to lead opportunities related to pre-due diligences, due-diligence (DD) for in-licensing, co-development, CDMO or acquisition of products and related assets (dossiers, analytical technology, etc.). This includes a thorough review and understanding of the offered products’ characteristics and performance based on quality attributes, robustness of formulation and overall analytics.<br>• Apply high quality standards/ principles during the different stages of product development, including review of drug product & API characterization, raw material quality attributes, drug-device compatibility, design of experiments, stability testing, analytical methods development & validation/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>• Evaluate the characterization and comparability plans and reports for complex dosage forms and propose technique as needed. Responsibility/accountability for characterization/comparability plan/protocols/reports for the in-licensing, co-development asset.<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/analytical 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><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# {#400,300#}#/video#]