Analytical Project Leader

Analytical Project Leader

The Analytical Research & Development department plays a critical role within Synthetic Molecules Technical Development by advancing analytical methodologies, supporting in-depth characterization of active pharmaceutical ingredients and dosage forms, and preparing regulatory documentation for global health authorities.

As an Analytical Project Leader, you will join a highly motivated and experienced team of analytical scientists and lead analytical development activities for synthetic molecule projects from early development through commercialization. This is an exciting opportunity to contribute to the development of innovative medicines in a dynamic, fast-paced, and scientifically driven environment.

Your Tasks:

• Develop and implement phase-appropriate analytical control strategies for drug substances and drug products
• Coordinate analytical development activities, including:
  • Method development and optimization
  • ICH-compliant method validation
  • Stability and degradation studies
  • Impurity profiling and analytical characterization
• Generate, evaluate, and document physical and chemical data in compliance with quality standards and timelines
• Collaborate closely with cross-functional stakeholders across development, quality, and external partners
• Supervise analytical testing activities within internal laboratories and external CLOs/CDMOs
• Coach technicians and junior scientists and act as a key contact person for project-related analytical topics
• Independently plan, execute, interpret, and document experiments and analytical results
• Support preparation of regulatory submission documents such as INDs and NDAs
• Ensure all activities are conducted in compliance with cGMP, safety, and regulatory requirements

Your Profile:

• Master’s degree or Ph.D. in Chemistry, Pharmacy, or a related scientific discipline
• Minimum 3 years of professional experience in analytical development for small molecule drug substances or drug products
• Strong expertise in:
  • HPLC / UPLC
  • Analytical method development and validation
  • ICH guidelines and compliance
• Experience with:
  • Forced degradation studies
  • Stability studies
  • Impurity profiling
  • Drug substance and drug product specifications
• In-depth understanding of synthetic chemistry, purification, and characterization techniques
• Experience preparing analytical documentation for regulatory submissions (IND/NDA)
• Strong quality mindset and attention to detail
• Fluent English skills