Analytical Project Leader Scientist

Analytical Project Leader Scientist (M/W/D)

Analytical Project Leader Scientist is responsible for developing analytical methods, characterizing drug substances/products, and supporting regulatory submissions. This role focuses on leading peptide analytical development across the full lifecycle in a cross-functional, fast-paced environment.

• Lead analytical development for peptide-based drug substances and products from early phase to commercialization
• Define and implement phase-appropriate control strategies
• Develop, validate, and oversee analytical methods (e.g., HPLC/UPLC, MS)
• Generate and interpret analytical data, ensuring quality, compliance, and timely delivery
• Prepare documentation for regulatory submissions (e.g., IND, NDA)
• Coordinate cross-functional collaboration and act as analytical project lead
• Supervise laboratory activities and external partners (CLOs/CDMOs)
• Ensure compliance with cGMP and regulatory standards

• MSc or PhD in Chemistry, Pharmacy, or related field with ≥3 years’ experience in peptide analytical development
• Strong expertise in peptide chemistry (synthesis, purification, characterization)
• Hands‑on experience with HPLC/UPLC and Mass Spectrometry for peptides
• Proven track record in ICH‑compliant method development and validation
• Experience in stability studies, forced degradation, and impurity profiling
• Solid understanding of peptide degradation pathways and specifications