Drug Product Project Leader

Drug Product Project Leader

Job Description Summary

To lead drug product teams during all stages of development and will be working on oral small molecules. You will use your strong communication, stakeholder management and influencing skills to effectively lead the drug product subteam and the transfer team. Your expertise will facilitate the planning and execution of smart DoE and scale-up / transfer campaigns to establish robust manufacturing processes and stable drug products suitable for human trials and commercial supplies following ICH principles.

Job Description

Key Responsibilities

• Lead and manage all Drug Product (DP) related technical development activities for assigned projects and you represent DP project teams in Technical Research and Development (TRD) sub-teams based on strong scientific and pharmaceutical development expertise.
• Lead, manage and support the DP and the transfer teams in line with Novartis values and behaviors. Build strong team spirit and promote knowledge exchange within and between teams.
• Formulate a sound DP project strategy incl. contingency planning and risk assessments as appropriate, involving functional experts, and ensure alignment with Pharmaceutical Development department and other departments and functions inside and outside of TRD and 3rd parties as appropriate.
• Ensure adherence to the scientific and project review process and through relevant scientific and project management governance boards. Ensure creation of high quality and scientifically sound DP development documents enabling a strong CMC submission package, and act as author, reviewer or approver for development documents in accordance with operational procedures and guidelines.
• Contribute to the generation of registration dossiers, answer DP related questions in internal and external audits, and support Health Authority requests.
• Assess, consolidate and negotiate resource needs and timelines for assigned projects within the DP project team and ensure resources are accurately forecasted in the planning systems.

Essential Requirements

• PhD in Pharmaceutical Sciences with 8+ years or MTech/M.Pharm in Pharmaceutical Technology/Pharmaceutics or relevant scientific field with 12+ years of relevant technical experience in Development of oral Pharmaceutical Drug Products with proven experience in leading project teams.
• Successfully demonstrated expertise in pharmaceutical oral dosage form development and manufacturing, i.e. formulations for Small Molecules including development, technology transfer and manufacturing.
• An in-depth understanding of material science principles, as applied to oral dosage forms, including the impact of physico-chemical properties of API and excipients on the drug product process and quality.
• Extensive experience with application of Quality by Design and Quality risk management principles and tools as well as a strong working knowledge of regulatory guidelines relevant to Drug Product Development, validation, risk management, testing and stability.
• Experience in applying data science, statistics, and DoE to enhance pharmaceutical development by providing a robust framework for data analysis, experimental design, and decision-making, leading to more effective and efficient drug development processes and documentation.
• Strong knowledge of laboratory and/or technical tools and pharmaceutical manufacturing technologies, as well as knowledge of relevant GLP, GMP regulations and policies.
• Strong presentation/communication and scientific/technical writing skills. Strong collaboration and stakeholder management skills in global environment.

Skills Desired

Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model

Experience Level

Senior Level