Analytical Project Leader

Roche seeks a Senior Analytical Project Leader in Basel to oversee analytical development for small molecule drugs, ensuring cGMP compliance and coordinating internal and external lab activities.

This position is designed for a seasoned chemist to lead analytical project work within small molecule drug development. The role focuses on coordinating efforts between internal laboratories and external partners while maintaining strict adherence to cGMP and quality standards.

Responsibilities

• Create a control strategy suitable for the specific development phase of drug substances and products.
• Work closely with stakeholders from different departments to ensure alignment.
• Manage analytical tasks such as data generation, method development, improvement, and validation, while ensuring proper documentation and quality.
• Mentor technicians and junior scientists, acting as the main contact for project information.
• Execute work in full compliance with cGMP, safety protocols, and regulatory rules.
• Oversee laboratory operations and testing performed by Contract Laboratory Organizations (CLOs) or Contract Development and Manufacturing Organizations (CDMOs).
• Independently plan and document experiments, preparing necessary materials for regulatory submissions like IND and NDA.

Requirements

• Master’s degree or Ph.D. in chemistry, pharmacy, or a related discipline.
• Minimum of three years of experience in analytical development for small molecule drug substances or products.
• Deep understanding of chemistry, including synthesis, purification, and characterization techniques.
• Strong expertise in using HPLC and UPLC technologies.
• Demonstrated ability to develop and validate analytical methods that meet ICH standards.
• Experience with degradation and stability studies for small molecules, including forced degradation and impurity profiling.
• Knowledge of key requirements for drug substance and product specifications.
• Fluent command of English.
• A strong focus on quality and excellent attention to detail.

Nice to have

• Proficiency in German.
• Digital skills to support digital transformation efforts.
• Familiarity with statistical analysis of analytical data.

About the company

Roche is a global company with over 100,000 employees dedicated to advancing science to prevent, stop, and cure diseases. The organization ensures everyone has access to healthcare by empowering employees to explore new possibilities, foster creativity, and maintain high ambitions to deliver life-changing solutions. The culture values personal expression, open dialogue, and genuine connections, ensuring employees are respected and accepted.

• Encourages personal expression and open dialogue.
• Values genuine connections where employees are respected.
• Mission-driven to prevent, stop, and cure diseases.
• Empowers creativity and high ambitions for healthcare solutions.
• Global team of over 100,000 employees advancing science.