Analytical Project Leader (m/f/d)

Responsibilities:

• Lead analytical development activities for peptide-based drug substance and drug product projects from early development through commercialization

• Develop phase-appropriate control strategies for drug substances and drug products

• Coordinate and oversee analytical activities, including method development, optimization, validation, and generation of physicochemical data

• Ensure high-quality documentation, timely delivery of results, and adherence to quality and regulatory standards

• Collaborate closely with cross-functional stakeholders across technical development, quality, manufacturing, and external partners

• Coach and guide technicians and junior scientists; act as a central analytical point of contact within project teams

• Ensure all work is performed in compliance with cGMP, safety, and regulatory requirements

• Supervise internal laboratory work and/or analytical activities at external CROs/CDMOs

• Independently plan, execute, and document experiments and contribute to regulatory submissions (e.g., IND, NDA)

Must haves:

• Master’s or Ph.D. in Chemistry, Pharmacy, or a related scientific discipline

• Minimum 3 years of industry experience in analytical development of peptide drug substances and/or drug products

• Strong expertise in peptide chemistry, including synthesis, purification, and characterization

• Hands-on experience with key analytical techniques such as HPLC, UPLC, and Mass Spectrometry (MS) for peptide analysis

• Proven experience with ICH-compliant analytical method development and validation

• Solid understanding of peptide degradation pathways, impurity profiling, and stability studies

• Experience defining specifications for peptide drug substances and/or drug products

• Strong quality mindset with excellent attention to detail

• Digital affinity to support data-driven and digital transformation initiatives; statistical data analysis skills are an advantage

• Open-minded, goal-oriented, and comfortable working in a fast-evolving environment

• Ability to view challenges as opportunities and collaborate respectfully under pressure

• Excellent command of English (written and spoken)