Formulation Project Leader / Formulation Project Leaderess

Formulation Project Leader (m/f/d)

**Location:** Basel, Switzerland #onsite

Summary

We are seeking a collaborative and scientifically proficient professional to take on the role of Formulation Project Leader within late-phase oral drug product development programs. In this position, you will lead formulation and manufacturing activities for small-molecule oral dosage forms, focusing on the design of robust formulations, development of scalable processes, and ensuring reliable project delivery.

Working with cross-functional development teams, you will integrate scientific and technical insights to establish coherent development strategies spanning from early clinical phases to scale-up, transfer, and regulatory submission. Your contributions will help build a deep understanding of how material attributes, formulation choices, and process parameters impact product performance and manufacturability, translating this knowledge into practical, high-quality development solutions.

You will be accountable for generating high-quality technical documentation, managing manufacturing activities, and coordinating development efforts to meet project timelines and quality expectations. Additionally, you will actively contribute to improving operational efficiency by applying structured, data-driven approaches and identifying opportunities for enhancing consistency and knowledge reuse across the portfolio.

About the Role

Your responsibilities will include but are not limited to:

• Lead formulation development and manufacturing activities for oral dosage forms across various development phases, focusing on designing robust, scalable formulations and ensuring project reliability.
• Develop and maintain project plans that align formulation, manufacturing, and supply activities with overall program objectives and timelines.
• Generate and integrate scientific insights into how drug substance and excipient properties, formulation design, and process parameters influence product performance and manufacturability.
• Apply structured, science-based methodologies (e.g., quality-by-design, modeling, and digital tools) to enhance understanding and support consistent, efficient development practices.
• Serve as a key partner within cross-functional drug product sub-teams, collaborating closely with Departments such as Pharmaceutical Development, Chemistry & Analytical Development, technical operations, QA, and others to ensure aligned and efficient execution.
• Contribute to high-quality technical documentation, including development reports, manufacturing instructions, and CMC documentation, while supporting responses to health authority queries and regulatory inspections.
• Foster effective collaboration and knowledge sharing within and across teams, driving continuous improvement in development methodologies and project execution efficiency.

What You'll Bring to the Role

• Advanced degree in Pharmaceutical Technology, Powder Process Engineering, or a related scientific field; a PhD or equivalent experience is preferred.
• A minimum of 3+ years of relevant industry experience in solid formulation and/or process development, preferably within the pharmaceutical development of oral dosage forms.
• A robust understanding of formulation design, manufacturing process development, scale-up, and process transfer, with a focus on creating reliable and efficient processes.
• Experience in applying structured experimental and data-driven approaches (e.g., modeling, PAT, DoE, statistical analysis) to support formulation and process development.
• Strong capability to work across functions, integrating diverse inputs and driving scientific problem solving in a clear and pragmatic manner within multidisciplinary teams.
• Excellent communication, scientific writing, and presentation skills, allowing you to convey complex topics clearly and facilitate efficient teamwork.
• A collaborative mindset with a passion for improving work structure and execution, ensuring clarity, consistency, and efficiency in development activities.
• Strong interpersonal skills, including the ability to coach and develop others.
• Familiarity with CMC documentation and GxP environments, including GMP and GLP expectations, with the capability to translate development work into compliant, high-quality documentation.

Commitment to Diversity and Inclusion

At Novartis, we are dedicated to fostering an outstanding and inclusive work environment, building diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodations to all individuals. If you require reasonable accommodation due to a medical condition or disability, or wish to receive more detailed information about the essential functions of this position, please send an e-mail to inclusion.switzerland@novartis.com detailing your request and contact information. Kindly include the job requisition number in your message.

Why Novartis

Helping individuals affected by disease and their families requires more than just innovative science; it takes a community of smart, passionate people like you. Together, we can collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more about our mission.

How to Apply

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

Benefits and Rewards

Discover the various ways we will support your personal and professional growth. Please refer to our handbook for more details (PDF 30 MB).

Division: Development
Business Unit: Development
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