Drug Product Project Leader – Oral Dosage Forms (80-100%)
Join to apply for the Drug Product Project Leader – Oral Dosage Forms (80-100%) role at Novartis.
Role Purpose: Novartis has a rich development portfolio of small molecules ready to develop into innovative, patient-centric oral dosage forms. As a Drug Product Project Leader (DPPL), you will lead formulation and manufacturing activities related to pharmaceutical development for small molecules (NCE). This role emphasizes extensive experience in pharmaceutical unit operations, late-phase development, scale-up, and transfer to commercial sites.
Summary: Location: Basel, Switzerland. You will manage drug product teams through all development stages, focusing on late clinical phases. Your work will involve oral small molecules and enabling formulation approaches. Strong communication, stakeholder management, and leadership skills are essential to lead the drug product and transfer teams effectively, ensuring robust manufacturing processes and stable drug products for trials and commercial supply following ICH guidelines.
Responsibilities include:
* Leading all technical development activities for assigned drug product projects and representing DP teams in TRD sub-teams.
* Managing and supporting the DP and transfer teams, fostering team spirit, knowledge exchange, and high performance.
* Formulating DP project strategies, including contingency planning and risk assessment, ensuring alignment with departments and external partners.
* Ensuring scientific and project review processes are followed, creating high-quality development documents for CMC submissions.
* Contributing to registration dossiers, responding to audit questions, and supporting health authority requests.
Qualifications:
* PhD in Pharmaceutical Sciences or related field (e.g., Pharmaceutical Technology, Chemical Engineering).
* At least 3 years of relevant experience in oral pharmaceutical development, leading project teams in a matrix environment.
* Expertise in oral dosage form development, manufacturing, scale-up, and enabling formulations for small molecules.
* Understanding of material science principles affecting drug product quality.
* Experience with QbD, risk management, regulatory guidelines, and technical writing.
* Preferred: experience applying data science, statistics, and DoE to pharmaceutical development.
Novartis values diversity and inclusion and is committed to providing accommodations for individuals with disabilities. For inquiries about accommodations, contact inclusion.switzerland@novartis.com, including the job requisition number.
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