Formulation Project Leader (m/f/d)

Novartis seeks a Senior Formulation Project Leader in Basel to oversee formulation development and manufacturing for oral dosage forms, ensuring robust processes, regulatory compliance, and cross-functional collaboration.

This position involves leading the formulation and manufacturing efforts for small-molecule oral dosage forms, spanning from early clinical phases through scale-up and regulatory submission. The role focuses on designing robust formulations, integrating scientific insights, and delivering high-quality technical documentation while coordinating cross-functional teams to meet project timelines and quality standards.

Responsibilities

• Direct formulation development and manufacturing activities for oral solid dosage forms throughout all development stages.
• Create and manage project plans that synchronize formulation, manufacturing, and supply chain activities with broader program goals.
• Analyze how drug substance properties, excipient characteristics, formulation design, and process parameters impact product performance and manufacturability.
• Utilize structured, science-based methodologies such as quality-by-design, modelling, and digital tools to improve development efficiency and decision-making.
• Collaborate closely with cross-functional teams, including Pharmaceutical Development, Chemistry & Analytical Development, technical operations, and QA.
• Prepare and maintain high-quality technical documentation, including development reports, manufacturing instructions, and CMC submissions, while supporting regulatory inspections.
• Foster knowledge sharing and continuous improvement within teams to enhance development efficiency and knowledge reuse across projects.

Requirements

• Advanced degree in Pharmaceutical Technology, Powder Process Engineering, or a related field; PhD or equivalent experience preferred.
• Minimum 3 years of industry experience in solid formulation or process development, preferably in pharmaceutical oral dosage forms.
• Deep understanding of formulation design, manufacturing process development, scale-up, and process transfer, with a focus on robustness.
• Experience applying structured experimental and data-driven approaches like modelling, PAT, DoE, and statistical analysis.
• Strong ability to work across functions, integrate diverse inputs, and drive scientific problem-solving in multidisciplinary teams.
• Excellent communication, scientific writing, and presentation skills, with the ability to convey complex topics clearly.
• Collaborative mindset with interest in improving work structure, execution, and development efficiency.
• Strong interpersonal skills, including coaching and developing team members.
• Familiarity with CMC documentation and GxP environments, including GMP and GLP expectations.

About the company

Novartis is dedicated to fostering an inclusive work environment with diverse teams that reflect the patients and communities served. The company is committed to providing reasonable accommodations to all individuals.

• Commitment to building an outstanding, inclusive work environment.
• Diverse teams representative of patients and communities.
• Commitment to reasonable accommodation for all individuals.