Analytical Project Leader
(m/f/d)
Freelance/temporary employment for a project Basel Stadt Start date: asap Reference number: 857732/1
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Responsibilities
1. Lead analytical development activities for synthetic molecule projects involving peptides, from early development through commercialization
2. Develop phase-appropriate control strategies for drug substances and drug products
3. Coordinate analytical activities, including generation of physical and chemical data, method development, method improvement, validation, and documentation
4. Collaborate closely with cross-functional stakeholders across multiple departments
5. Coach technicians and junior scientists, serving as the central point of contact for project-related analytical topics
6. Ensure all analytical work complies with cGMP (where applicable), safety standards, and regulatory expectations
7. Oversee internal laboratory activities and manage analytical testing performed at external partners (CLOs/CDMOs)
8. Independently plan, execute, and document experiments and contribute to regulatory submissions such as IND and NDA
Profile
9. Master’s or in chemistry, pharmacy, or a related scientific discipline
10. Strong industry experience in analytical development for peptide drug substances and drug products
11. Deep knowledge of peptide chemistry, including synthesis, purification, and characterization
12. Expertise in HPLC, UPLC, MS, and related analytical techniques for peptide analysis
13. Proven ability to develop and validate ICH-compliant analytical methods
14. Proficiency in degradation and stability studies, including forced degradation and impurity profiling
15. Solid understanding of requirements for peptide drug substance and drug product specifications
16. Strong quality mindset with excellent attention to detail
17. Digital fluency and familiarity with statistical analysis of analytical data
18. Open-minded, goal-oriented, and comfortable working in a fast-moving environment
19. Strong collaboration skills and ability to work respectfully with stakeholders under pressure
Benefits
20. Opportunity to lead analytical development for innovative peptide therapeutics with real clinical impact
21. Work within a highly skilled analytical science team in a dynamic, cross-functional environment
22. Involvement in both laboratory-based activities and strategic project leadership, including regulatory contributions