Analytical Project Leader (80-100%) (m/f/d)

Position Overview

Located in Basel, Switzerland, this role focuses on providing vital support in project management within the Analytical Research & Development (ARD) sector. The ARD department plays a crucial role in the characterization and analysis of Drug Substances and Drug Products, spanning from the discovery phase to commercial production.

Main Responsibilities

• Contribute as a key member of a global CMC subteam, leading the technical development of Drug Substances and Drug Products throughout clinical development phases.
• Manage analytical activities within Technical CMC project teams, including defining control and specification strategies for new modality drug substances and products.
• Lead an analytical subteam, preparing project plans and ensuring adherence to quality standards, timelines, and budget constraints.
• Accurately forecast resource and cost demands for assigned projects.
• Ensure the timely issuance of essential analytical source documents such as Specifications and Validation reports.
• Provide scientific input for analytical CMC documents and support regulatory submissions.
• Collaborate with internal and external stakeholders in drug development and mentor analytical experts.
• Oversee outsourced analytical activities at CROs/CDMOs while managing external partnerships effectively.

Educational Background

• PhD in analytical chemistry or a related field, complemented by a minimum of five years’ experience in pharmaceutical analytical development, preferably with sterile parenteral products.
• Experience in oligonucleotide analytics is advantageous.
• Proven leadership skills in managing development projects in a global matrix environment.
• Strong knowledge of regulatory guidelines pertinent to analytical development.
• A collaborative approach, self-driven mindset, and high learning agility are essential traits.
• Experience in a cGMP environment with a strong focus on quality.
• Intrinsic motivation to work with new developmental compounds, showing a willingness to exceed expectations for success.
• Broad scientific knowledge across chemistry, pharmaceutical, or analytical sciences, with the ability to thrive in dynamic settings.
• Proficiency in scientific writing, technical communication, and digital tools for enhanced productivity.
• Fluency in English is required, with additional languages such as German or French considered a plus.

Commitment to Diversity and Inclusion

Novartis values diversity and is dedicated to fostering an inclusive work environment that reflects the communities we serve, helping to ensure a comprehensive representation across teams.

Why Choose Novartis

Joining Novartis means being part of a community that values collaboration, innovation, and a shared commitment to improving lives. Explore how your contributions can lead to breakthroughs that significantly impact patient care and together, create a brighter future.

Benefits and Rewards

Novartis offers a comprehensive handbook detailing various ways in which we support personal and professional development, ensuring our team members thrive in their roles.