Formulation Project Leader (m/f/d)

Role Purpose

Take on the role of Formulation Project Leader across late phase oral drug product development programs. Lead formulation and manufacturing activities for small-molecule oral dosage forms, with a strong focus on designing robust formulations, developing scalable processes, and ensuring reliable project delivery.

Working across cross-functional development teams, integrate scientific and technical insights to establish coherent development strategies from early clinical phases through scale-up, transfer, and regulatory submission. Contribute to building a deep understanding of how material attributes, formulation choices, and process parameters drive product performance and manufacturability, and translate this into practical, high-quality development solutions.

Be accountable for the generation of high-quality technical documentation, the preparation and oversight of manufacturing activities, and the coordination of development efforts to meet project timelines and quality expectations. Actively contribute to evolving ways of working by applying structured, data-driven approaches and identifying opportunities to enhance efficiency, consistency, and knowledge reuse across the portfolio.

Responsibilities

• Lead formulation development and manufacturing process activities for oral dosage forms across development phases, with a strong focus on designing robust, scalable formulations and processes and ensuring reliable project delivery.
• Develop and maintain project plans that align formulation, manufacturing, and supply activities with overall program objectives and timelines.
• Generate and integrate scientific insight into how drug substance-and-excipient-properties, formulation design, and process parameters influence product performance, manufacturability, and consistency.
• Apply structured, science-based approaches (e.g., quality-by-design, modelling, and digital tools) to enhance understanding, enable informed decision-making, and support consistent and efficient development practices.
• Act as a key partner within cross-functional drug product sub-teams, collaborating closely with e.g. Pharmaceutical Development, Chemistry & Analytical Development, technical operations, QA and other relevant functions to ensure aligned and efficient execution.
• Own and contribute to high-quality technical documentation, including development reports, manufacturing instructions, and CMC documentation, and support responses to health authority questions and regulatory inspections.
• Promote effective collaboration and knowledge sharing within and across teams, contributing to continuous improvement in development approaches, efficiency of execution, and reuse of knowledge across projects.
• Take diligently accountability for handling timely Change Requests and deviations-in quality systems. Act as Initiator and owner of change requests and related tasks. Act as Initiator and owner of deviations and related tasks and actions on need basis.
• Support the creation of SAP-information on need basis.

Qualifications

• Advanced degree in Pharmaceutical Technology, Powder Process Engineering, or a related scientific field; PhD or equivalent experience is valued.
• Minimum 5+ years of relevant industry experience in solid formulation and/or process development, preferably within pharmaceutical development of oral dosage forms.
• Advanced understanding of formulation design, manufacturing process development, scale-up, and process transfer, with a focus on creating robust and reliable processes.
• Proficient in applying structured experimental and data-driven approaches (e.g., modelling, PAT, DoE, statistical analysis, or related methodologies) to support formulation and process development.
• Strong ability to work across functions, integrate diverse inputs, and drive scientific problem solving in a clear and pragmatic way within multidisciplinary teams.
• Excellent communication, scientific writing, and presentation skills, with the ability to convey complex topics clearly and contribute to efficient and aligned teamwork.
• A collaborative mindset combined with an interest in improving how work is structured and executed, including the ability to bring clarity, consistency, and efficiency to development activities.
• Strong interpersonal skills, including coaching other and developing people.
• In depth knowledge of CMC documentation and GxP environments, including GMP and GLP expectations, with an understanding of how to translate development work into compliant and high-quality documentation.

Benefits & Rewards

Expected Annual Base Salary Range for role: CHF 93,800 to CHF 174,200. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.