• Conduct analysis and characterization of peptides using various analytical techniques
• Ensure that all critical analytical parameters for peptides — such as purity, identity, and content — are properly defined and validated
• Confirm the use of appropriate, validated methods for batch verification, including HPLC, LC-MS, and NMR
• Oversee stability studies according to ICH guidelines to ensure the peptide maintains integrity in its solid form
• Set and maintain acceptance criteria for release testing, aligned with regulatory and internal quality standards
• Review and approve the CMO’s manufacturing processes, including: Drying and solidification techniques (e.g., lyophilization), Storage conditions (temperature, humidity, packaging), Use of excipients, if applicable
• Define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) relevant to solid-state peptides — such as residual solvents, moisture content, and solid form stability
• Ensure appropriate controls are in place to detect impurities or degradation, such as aggregation, oxidation, deamidation, and racemization
• Review and approve the analytical methods used by the CMO to ensure they meet regulatory and scientific standards
• Oversee identity testing (to confirm correct amino acid sequence) and impurity profiling
• Ensure that all testing and controls at the CMO are performed under GMP-compliant conditions
• Participate in batch record review and deviation management, including the evaluation of borderline or out-of-specification results
• Monitor ongoing trend analysis to identify potential quality or process issues early

• 5 to 10 years of experience in analytical chemistry applied to peptides
• Proficiency in analytical techniques for peptides, including
• HPLC, LC-MS, CE, CD Spectrometry, NMR Spectroscopy
• Experience in method development and validation
• Familiarity with GMP regulations and pharmaceutical compliance standards
• Advanced English proficiency (mandatory), German knowledge is a plus
• Ability to work in a team and in a highly regulated environment

German knowledge

• Opportunity to work in a leading pharmaceutical company
• Professional development in an international environment
• Competitive salary and attractive benefits package