Drug Product Project Leader / Drug Product Project Leaderess

Job ID

REQ-10032015

Mar 21, 2025

Switzerland

Summary

Location: Basel, Switzerland

Role Purpose: Novartis maintains a rich development portfolio of small molecules poised for transformation into innovative, patient-centric oral dosage forms. As a Drug Product Project Leader (DPPL) specializing in oral dosage forms, you will oversee and manage the formulation and manufacturing activities linked to pharmaceutical development for small molecules (New Chemical Entities; NCE). This role emphasizes the importance of extensive experience in pharmaceutical unit operations, particularly in late-phase processes including scale-up and transfer to commercial sites.

You will lead drug product teams through all developmental stages with a specific focus on late clinical phases. Your work will center on oral small molecules, particularly in developing enabling formulation approaches. Utilizing your strong communication, stakeholder management, and influencing skills, you will effectively guide the drug product sub-team and transfer team within a matrix organization. Your expertise will be instrumental in planning and executing smart DoE and scale-up/transfer campaigns, establishing robust manufacturing processes and stable drug products suitable for human trials and commercial supplies in accordance with ICH principles.

About the Role

Your responsibilities will include but are not limited to:

• Lead and manage all Drug Product (DP) related technical development activities for assigned projects while representing DP project teams in Technical Research and Development (TRD) sub-teams through your strong scientific and pharmaceutical development expertise.
• Support the DP and transfer teams in alignment with Novartis values, fostering a strong team spirit and promoting knowledge exchange within and between teams. Motivate and coach team members to achieve high performance.
• Formulate a sound DP project strategy, including contingency planning and risk assessments, while ensuring alignment with the Pharmaceutical Development department and other internal and external stakeholders.
• Ensure compliance with the scientific and project review processes through relevant governance boards, producing high-quality and scientifically sound DP development documents to enable a strong CMC submission package.
• Contribute to the generation of registration dossiers, address DP-related queries during internal and external audits, and support Health Authority requests.

What You’ll Bring to the Role

• PhD in Pharmaceutical Sciences or a relevant scientific field (e.g., Pharmaceutical Technology, Chemical Engineering).
• A minimum of 3 years of relevant technical experience in the development of oral pharmaceutical drug products, with proven experience in leading project teams in a matrix organization.
• Strong expertise in pharmaceutical oral dosage form development, manufacturing, and scale-up for small molecule formulations, including enabling formulations, manufacturing technologies, and scale-up principles.
• An understanding of material science principles as they pertain to oral dosage forms, including the impact of physico-chemical properties of API and excipients on drug product processes and quality.
• Experience with the application of Quality by Design and quality risk management principles, along with a good working knowledge of regulatory guidelines relevant to drug product development and validation.
• Ideally, experience in the application of data science, statistics, and DoE to enhance pharmaceutical development through robust data analysis and experimental design methodologies.

Commitment to Diversity and Inclusion

Novartis is dedicated to cultivating a diverse and inclusive work environment with teams that represent the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to providing reasonable accommodations to all individuals. If you require accommodation due to a medical condition or disability during the recruitment process, please send an email to Show e-mailm">Show e-mail, stating your request and contact information. Include the job requisition number in your message.

Why Novartis

Helping individuals with diseases and their families requires more than just innovative science; it takes a community of smart, passionate people like you. Together, we can achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more about us.

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Benefits and Rewards

Explore our handbook to understand the various ways we support your personal and professional growth: Benefits and Rewards.

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Division

Development

Business Unit

Innovative Medicines

Location

Switzerland

Site

Basel (City)

Company / Legal Entity

C028 (FCRS = CH028) Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment with diverse teams that represent the patients and communities we serve.