Analytical Project Lead (m/f/d)

Novartis Pharma Schweiz AG seeks a Senior Analytical Project Lead in Basel to drive analytical strategy for biologic products, managing development activities and regulatory submissions.

The company is looking for a senior professional to define and execute the analytical project strategy for innovative biologic therapies. This role involves establishing robust control strategies tailored to development phases and serving as the primary representative for the analytical discipline within global CMC project teams. The position requires leading a sub-team in a matrix structure to ensure technical development goals are met.

Responsibilities

• Oversee all analytical tasks related to drug substance and drug product development, including stability and release testing, method validation, transfer, and specification setting.
• Direct the timely production of high-quality source documents for regulatory submissions and review associated regulatory materials.
• Serve as the technical expert during audits and inspections, interacting directly with health authorities for scientific advice and submission support.
• Manage the analytical budget and plan necessary resources for project execution.
• Identify potential scientific, technological, or GMP-related challenges early and propose effective solutions to management.
• Facilitate clear communication across various organizational levels, including project management, line functions, and senior leadership.

Requirements

• A PhD degree plus at least eight years of experience in Biologics CMC development, or a university life-science degree with equivalent industry experience.
• Deep theoretical and practical scientific expertise in analytical methods for biologic drug development.
• Demonstrated scientific leadership capability in advancing innovative molecules from research into development stages.
• Comprehensive understanding of regulatory requirements and substantial experience with IND and BLA submissions.
• Proven ability to lead matrix teams effectively, supported by strong interpersonal and communication skills.
• Fluency in English.

What the company offers

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

About the company

Novartis Pharma Schweiz AG is dedicated to reimagining medicine together, focusing on the creation of innovative healthcare solutions.

• Commitment to collaborative innovation in medicine.