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 solid 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 i

📌 Drug Product Project Leader (Hyderabad)
🏢 Novartis
📍 Hyderabad