Analytical Project Lead (m/f/d)

Novartis seeks an Analytical Project Lead in Basel to direct analytical strategy for biologics development, lead cross-functional teams, and ensure regulatory compliance for innovative products.

This position is located in Basel, Switzerland, and involves joining a global network of analytical project managers across all Novartis biologics research and development sites in Europe. The role focuses on steering the analytical aspects of highly innovative biologic products from early research through to technical development and regulatory submission.

Responsibilities

• Define and oversee the analytical project strategy, including the development of phase-appropriate control strategies to support the technical advancement of complex biologic products.
• Direct and coordinate the analytical sub-team within a matrix structure while serving as the analytical discipline representative in global CMC project teams.
• Oversee all analytical activities related to drug substance and drug product development, encompassing release and stability testing, molecule characterization, method development, transfer, validation, specification setting, and knowledge transfer.
• Ensure the timely delivery of high-quality source documents for regulatory submissions, review regulatory documentation, and engage with health authorities during audits and scientific advice meetings.
• Facilitate effective communication across various organizational interfaces, including project management, line functions, and senior leadership.
• Proactively identify scientific, technological, and GMP-related challenges, propose innovative solutions, and escalate critical issues to the appropriate management levels.
• Prepare and manage high-quality analytical registration documents for health authority submissions, act as a technical expert during audits and inspections, and maintain direct interaction with regulatory bodies.
• Manage the analytical budget and allocate resources effectively to support project goals.

Requirements

• Hold a PhD or a university degree in life sciences, complemented by at least eight years of relevant experience in biologics CMC development or equivalent industry experience.
• Demonstrate excellent theoretical and deep scientific expertise in analytical areas within biologic drug development.
• Exhibit strong scientific leadership capabilities, with a proven track record of advancing innovative molecules from research to development.
• Possess a thorough understanding of regulatory expectations and requirements, along with substantial experience in IND/BLA submissions.
• Show strong experience in leading matrix teams and possess excellent communication skills.
• Be proficient in English.

What the company offers

• Performance-based bonus tied to specific performance metrics.
• Competitive benefits including insurance plans, retirement plans, wellbeing resources, and global recognition programs.
• Flexible and hybrid working arrangements where feasible.
• Minimum 14 weeks of paid parental leave.

About the company

Novartis is dedicated to reimagining medicine together and is committed to working with and providing reasonable accommodation to all individuals.

• Novartis is dedicated to reimagining medicine together.
• Novartis is committed to working with and providing reasonable accommodation to all individuals.