We are recruiting for Analytical Project Lead!
In this role, you will join a highly motivated and experienced team of analytical scientists and take a leading role in the analytical development of synthetic molecule projects with a focus on peptides, from early development through commercialization. This is an exciting opportunity to apply your expertise in a dynamic, fast-paced environment and make a meaningful contribution to the development of life-changing medicines.
The ideal candidate combines strong scientific expertise with project leadership skills and thrives in a collaborative, cross-functional setting.
Key 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-Have Qualifications
* 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)
Nice-to-Have Qualifications
* Experience in analytical development of oligonucleotides or biologically derived molecules
* Proficiency in German
* Experience with liquid formulations, including:
* Understanding physicochemical properties of peptides and their impact on formulation development
* Designing and executing systematic stability studies for peptide liquid formulations under various conditions
#J-18808-Ljbffr