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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.
Tasks:
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
Qualifications:
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
Conditions:
Start: ASAP
Duration: 6 months
Workload: Full-time
Location: Onsite Basel/Aarau